JP7641419B2 - Systems, devices and methods for insertion of analyte sensors - Patents.com - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/784,074, filed December 21, 2018, which is incorporated herein by reference in its entirety for all purposes. This application is also a divisional application of Japanese Patent Application No. 2021-531135, filed June 6, 2019.

The subject matter described herein generally relates to systems, devices, and methods for using an applicator to insert at least a portion of an analyte sensor into a subject's body.

Detecting and/or monitoring the levels of analytes such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc., can be critical to the health of individuals with diabetes. Patients with diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients generally need to monitor their glucose levels to ensure they remain within a clinically safe range, and this information can be used to determine if and/or when insulin is needed to reduce glucose levels in the body, or when additional glucose is needed to increase glucose levels in the body.

A growing body of clinical data demonstrates a strong correlation between frequency of glucose monitoring and glycemic control. However, despite this correlation, many individuals diagnosed with the diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, latitude to test, discomfort associated with glucose testing, and cost.

To improve patient compliance with a frequent glucose monitoring schedule, an in vivo analyte monitoring system can be utilized in which a sensor control device can be worn on the body of an individual needing analyte monitoring. To improve comfort and convenience for the individual, the sensor control device can have a small form factor and can be assembled and applied by the individual using a sensor applicator. The application process includes inserting at least a portion of a sensor that senses a user's analyte level into a bodily fluid located in a layer of the human body using an applicator or insertion mechanism to contact the sensor with the bodily fluid. The sensor control device can also be configured to transmit analyte data to another device from which the individual or the individual's health care provider (HCP) can review the data and make treatment decisions.

While current sensors may be convenient for users, they are vulnerable to malfunctions. These malfunctions may be caused by user error, lack of proper training, inadequate user coordination, overly complicated procedures, physiological responses to an inserted sensor, and other issues. For example, some prior art systems may be too dependent on the individual user to precisely assemble and deploy the sensor control device and applicator. Other prior art systems may utilize sharp insertion and withdrawal mechanisms that are prone to trauma to the surrounding tissue at the sensor insertion site, which may lead to inaccurate analyte level measurements. These challenges, and others described herein, may lead to improper insertion and/or suboptimal analyte measurements by the sensor, which may result in failure to properly monitor a patient's analyte levels.

Therefore, there is a need for more reliable sensor insertion devices, systems, and methods that are easy for patients to use and less prone to error.

Provided herein are exemplary embodiments of systems, devices, and methods for assembly and use of an applicator and a sensor control device of an in vivo analyte monitoring system. The applicator can be provided to a user in a sterile package that contains an electronics housing of the sensor control device. According to some embodiments, a structure separate from the applicator, such as a container, can also be provided to a user as a sterile package that contains a sensor module and a sharps module. A user can connect the sensor module to the electronics housing and connect the sharps to the applicator through an assembly process that involves inserting the applicator into the container in a specified manner. In other embodiments, the applicator, the sensor control device, the sensor module, and the sharps module can be provided in a single package. The applicator can be used to position the sensor control device on a human body such that a sensor contacts the wearer's bodily fluids. The embodiments provided herein are improvements to prevent or reduce the likelihood that a sensor will be improperly inserted or damaged, or will induce an adverse physiological response. Other improvements and advantages are provided as well. Various configurations of these devices are described in detail by way of several embodiments, which are merely examples.

Other systems, devices, methods, features, and advantages of the subject matter described herein will be or become apparent to one of ordinary skill in the art upon examination of the following drawings and Detailed Description. Such additional systems, devices, methods, features, and advantages are intended to be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. Features of the example embodiments should not be construed as limiting the appended claims unless those features are expressly recited in the claims.

Details regarding the structure and operation of the subject matter described herein may become apparent by examination of the accompanying drawings, in which like reference numerals refer to like parts. The components in the drawings are not necessarily to scale, emphasis instead being placed on illustrating the principles of the subject matter. Moreover, all figures are intended to convey concepts, in which relative sizes, shapes, and other detailed attributes may be depicted generally, without exaggeration or precision.

System overview of sensor applicators, reader devices, monitoring systems, networks, and remote systems FIG. 1 is a block diagram illustrating an example embodiment of a reader device. 1 is a block diagram of an exemplary embodiment of a sensor control device; 1 is a block diagram of an exemplary embodiment of a sensor control device; 2 is a progression diagram of an exemplary embodiment of the assembly and application of the system of FIG. 1 incorporating a two-part architecture; Continuation of FIG. Continuation of FIG. Continuation of FIG. Continuation of Figure 3D Continuation of Figure 3E Continued from Figure 3F FIG. 1 is a side view of an exemplary embodiment of an applicator device coupled with a cap; FIG. 1 is a side perspective view of an exemplary embodiment of a decoupled applicator device and cap; FIG. 1 is a perspective view of an exemplary embodiment of a distal end of an applicator device and an electronics housing. FIG. 1 is a proximal perspective view of an exemplary embodiment of a tray with a sterilization lid attached thereto; FIG. 1 is a proximal perspective cutaway view of an exemplary embodiment of a tray having a sensor delivery component; Proximal perspective view of the sensor delivery component 1 is a side view of an exemplary embodiment of a housing; 1 is a perspective view of an exemplary embodiment of a distal end of a housing; 1 is a side cross-sectional view of an exemplary embodiment of a housing; 1 is a side view of an exemplary embodiment of a sheath; 1 is a perspective view of an exemplary embodiment of a proximal end of a sheath; FIG. 13 is a close-up perspective view of an exemplary embodiment of a distal side of a detent snap on a sheath; 1 is a side view of an exemplary embodiment of a sheath feature; FIG. 1 is an end view of an exemplary embodiment of a proximal end of a sheath; FIG. 1 is a perspective view of an exemplary embodiment of a compressible distal end of an applicator; 1 is a cross-sectional view of an exemplary geometry for an embodiment of a compressible distal end of an applicator; 1 is a cross-sectional view of an exemplary geometry for an embodiment of a compressible distal end of an applicator; 1 is a cross-sectional view of an exemplary geometry for an embodiment of a compressible distal end of an applicator; 1 is a cross-sectional view of an exemplary geometry for an embodiment of a compressible distal end of an applicator; 1 is a cross-sectional view of an exemplary geometry for an embodiment of a compressible distal end of an applicator; FIG. 1 is a perspective view of an exemplary embodiment of an applicator having a compressible distal end; 1 is a cross-sectional view of an exemplary embodiment of an applicator having a compressible distal end; FIG. 1 is a proximal perspective view of an exemplary embodiment of a sensor electronics carrier; FIG. 1 is a distal perspective view of an exemplary embodiment of a sensor electronics carrier; FIG. 1 is a proximal perspective view of an exemplary embodiment of a sharps carrier; 1 is a side cross-sectional view of an exemplary embodiment of a sharps carrier; FIG. 1 is a top perspective view of an exemplary embodiment of a sensor module; 1 is a bottom perspective view of an exemplary embodiment of a sensor module; FIG. 1 is a perspective view of an exemplary embodiment of a sensor connector; FIG. 1 is a perspective view of an exemplary embodiment of a sensor connector in a compressed state; 1 is a perspective view of an exemplary embodiment of a sensor; 1 is a bottom perspective view of an exemplary embodiment of a sensor module assembly; FIG. 1 is a top perspective view of an exemplary embodiment of a sensor module assembly; FIG. 1 is a partial exploded view of an exemplary embodiment of a sensor module assembly; FIG. 1 is a partial exploded view of an exemplary embodiment of a sensor module assembly; FIG. 1 is a perspective view of an exemplary embodiment of a sharps module; FIG. 13 is a perspective view of another exemplary embodiment of a sharps module; 1 is a side view of another exemplary embodiment of a sharps module; FIG. 13 is a perspective view of another exemplary embodiment of a sharps module; 1 is a cross-sectional view of an exemplary embodiment of an applicator; 1 is a flow chart of an exemplary embodiment of a method for sterilizing an applicator assembly. Photographs of exemplary embodiments of sharps tips Photographs of exemplary embodiments of sharps tips FIG. 1 is a perspective view of an exemplary embodiment of a sharps module; FIG. 1 is a perspective view of an exemplary embodiment of a sharps module; 1 is a cross-sectional view of an exemplary embodiment of an applicator; FIG. 1 is an exploded view showing various components of an exemplary embodiment of an applicator; 1A-1C are cross-sectional views of an exemplary embodiment of an applicator during various stages of deployment; 1 is a perspective view of an exemplary embodiment of a sheath; FIG. 1 is a perspective view of an exemplary embodiment of a sensor electronics carrier; 1A-1C are cross-sectional views of an exemplary embodiment of an applicator during various stages of deployment; FIG. 1 is a perspective view of an exemplary embodiment of a sheath-sensor electronics carrier assembly; FIG. 1 is a partial close-up view of an exemplary embodiment of a sheath-sensor electronics carrier assembly; 1A-1C are cross-sectional views of an exemplary embodiment of an applicator during various stages of deployment; FIG. 1 is a partial close-up view of an exemplary embodiment of a sheath-sensor electronics carrier assembly; FIG. 1 is a partial close-up view of an exemplary embodiment of a sheath-sensor electronics carrier assembly; 1A-1C are cross-sectional views of an exemplary embodiment of an applicator during various stages of deployment; FIG. 1 is a partial close-up view of an exemplary embodiment of a sheath-sensor electronics carrier assembly; FIG. 1 is a partial close-up view of an exemplary embodiment of a sheath-sensor electronics carrier assembly; 1 is a perspective view of an exemplary embodiment of an applicator; FIG. 1 is a front side view of an exemplary embodiment of an applicator. 1 is a rear side view of an exemplary embodiment of an applicator; FIG. 1 is a left side view of an exemplary embodiment of an applicator. FIG. 1 is a right side view of an exemplary embodiment of an applicator. FIG. 1 is a top view of an exemplary embodiment of an applicator. FIG. 1 is a bottom view of an exemplary embodiment of an applicator. FIG. 1 is a perspective view of another exemplary embodiment of an applicator; FIG. 1 is a front side view of another exemplary embodiment of an applicator. FIG. 1 is a rear side view of another exemplary embodiment of an applicator; FIG. 1 is a left side view of another exemplary embodiment of an applicator; FIG. 1 is a right side view of another exemplary embodiment of an applicator; FIG. 1 is a top view of another exemplary embodiment of an applicator; FIG. 1 is a bottom view of another exemplary embodiment of an applicator. FIG. 1 is a perspective view of an exemplary embodiment of a sensor control device. FIG. 1 is a front side view of an exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of an exemplary embodiment of a sensor control device; FIG. 1 is a left side view of an exemplary embodiment of a sensor control device; FIG. 1 is a right side view of an exemplary embodiment of a sensor control device. FIG. 1 is a top view of an exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of an exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; 1 is a perspective view of an exemplary embodiment of an applicator; FIG. 1 is a front side view of an exemplary embodiment of an applicator; 1 is a rear side view of an exemplary embodiment of an applicator; FIG. 1 is a left side view of an exemplary embodiment of an applicator. FIG. 1 is a right side view of an exemplary embodiment of an applicator. FIG. 1 is a top view of an exemplary embodiment of an applicator. FIG. 1 is a bottom view of an exemplary embodiment of an applicator. FIG. 1 is a perspective view of another exemplary embodiment of an applicator; FIG. 1 is a front side view of another exemplary embodiment of an applicator; FIG. 1 is a rear side view of another exemplary embodiment of an applicator; FIG. 1 is a left side view of another exemplary embodiment of an applicator; FIG. 1 is a right side view of another exemplary embodiment of an applicator; FIG. 1 is a top view of another exemplary embodiment of an applicator; FIG. 1 is a bottom view of another exemplary embodiment of an applicator. FIG. 1 is a perspective view of an exemplary embodiment of a sensor control device. FIG. 1 is a front side view of an exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of an exemplary embodiment of a sensor control device; FIG. 1 is a left side view of an exemplary embodiment of a sensor control device; FIG. 1 is a right side view of an exemplary embodiment of a sensor control device. FIG. 1 is a top view of an exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of an exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device; FIG. 1 is a perspective view of another exemplary embodiment of a sensor control device; FIG. 1 is a front side view of another exemplary embodiment of a sensor control device; FIG. 1 is a rear side view of another exemplary embodiment of a sensor control device; FIG. 1 is a left side view of another exemplary embodiment of a sensor control device; FIG. 1 is a right side view of another exemplary embodiment of a sensor control device; FIG. 1 is a top view of another exemplary embodiment of a sensor control device; FIG. 1 is a bottom view of another exemplary embodiment of a sensor control device;

Before describing the present subject matter in detail, it is to be understood that the present disclosure is not limited to particular embodiments described herein, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, as the scope of the present disclosure will be limited only by the appended claims.

As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present disclosure is not entitled to antedate such publications by reason of their prior disclosure. Further, the dates of publications provided herein may be different from the actual publication dates, which may need to be independently confirmed.

In general, embodiments of the present disclosure include systems, devices, and methods for the use of an analyte sensor insertion applicator for use with an in vivo analyte monitoring system. Thus, many embodiments include an in vivo analyte sensor, where at least a portion of the sensor is positioned or structurally configured to be positioned on a user's body to obtain information regarding at least one analyte in the body. However, it should be noted that the embodiments disclosed herein can also be used with in vivo analyte monitoring systems incorporating in vitro functionality, as well as purely in vitro or ex vivo analyte monitoring systems, including completely non-invasive systems.

Additionally, for each and every embodiment of the methods disclosed herein, systems and devices capable of performing each of these embodiments are within the scope of the present disclosure. For example, sensor control device embodiments are disclosed, which may have one or more sensors, analyte monitoring circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power sources, communication circuitry, transmitters, receivers, processors, and/or controllers (e.g., for executing instructions stored in memory) that may perform or facilitate the execution of any and all method steps. These sensor control device embodiments may be used, or may be enabled to be used, to implement steps performed by the sensor control device from any of the methods described herein.

As discussed above, numerous embodiments of systems, devices, and methods are described herein that provide improved assembly and use of analyte sensor insertion devices for use with in vivo analyte monitoring systems. In particular, some embodiments of the present disclosure are designed to improve the method of sensor insertion into an in vivo analyte monitoring system, particularly to minimize trauma to the insertion site during the sensor insertion process. Some embodiments include, for example, a powered sensor insertion mechanism configured to operate at a controlled speed that is faster than a manual insertion mechanism to reduce trauma to the insertion site. In other embodiments, an applicator having a compressible distal end can stretch and flatten the skin surface at the insertion site, thereby reducing the likelihood of failed insertion due to skin tenting. In still other embodiments, a sharp with an offset tip, or a sharp manufactured using a plastic material or a coining manufacturing process, can also reduce trauma to the insertion site. In short, these embodiments can improve the likelihood of successful sensor insertion and reduce the amount of trauma to the insertion site, to name a few of their advantages.

However, before describing these aspects of the embodiments in detail, it is advisable to first describe examples of devices that may reside within, such as an in vivo analyte monitoring system, and examples of their operation, all of which may be used in conjunction with the embodiments described herein.

There are various types of in vivo analyte monitoring systems. For example, a "Continuous Analyte Monitoring" system (or "Continuous Glucose Monitoring" system) can transmit data from a sensor control device to a reader device continuously, without prompting, e.g., automatically, e.g., according to a schedule. As another example, a "Flash Analyte Monitoring" system (or "Flash Glucose Monitoring" system or simply "Flash" system) can transmit data from a sensor control device in response to a scan or request for data by a reader device, such as using Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocols. In vivo analyte monitoring systems can also operate without the need for finger stick calibration.

In vivo analyte monitoring systems can be distinguished from "in vitro" systems, which contact a biological sample outside the body (or "ex vivo") and typically include a measurement device having a port for receiving an analyte test strip carrying a user's bodily fluid, which can be analyzed to determine the user's blood glucose level.

An in-vivo monitoring system may include a sensor that contacts a user's bodily fluid while positioned in vivo and senses an analyte level contained therein. The sensor may be part of a sensor control device that resides on the user's body and contains electronics and a power source that effectuate and control the sensing of the analyte. Sensor control devices and variations thereof may also be referred to as "sensor control units," "on-body electronics" devices or units, "on-body" devices or units, or "sensor data communication" devices or units, to name a few.

In-vivo monitoring systems can also include devices that receive sensed analyte data from the sensor control device and process and/or display the sensed analyte data to a user in any number of formats. These devices and variations thereof may also be referred to as "handheld devices," "reader devices" (or simply "readers"), "handheld electronics" (or simply "handhelds"), "portable data processing" devices or units, "data receivers," "receiver" devices or units (or simply "receivers"), or "remote" devices or units, to name a few. Other devices, such as personal computers, have also been utilized with or incorporated into in-vivo and in-vitro monitoring systems.

Exemplary Embodiments of an In-Vivo Analyte Monitoring System FIG. 1 is a conceptual diagram illustrating one exemplary embodiment of an analyte monitoring system 100 including a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on a user's skin where a sensor 104 is maintained in place for a period of time by an adhesive patch 105. The sensor control device 102 is further described in FIGS. 2B and 2C, which can communicate with the reader device 120 via a communication path 140 using wired or wireless techniques. Exemplary wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), etc. A user can monitor applications installed in memory on the reader device 120 using a screen 122 and input 121, and the device's battery can be recharged using a power port 123. Although only one reader device 120 is shown, the sensor control device 102 can communicate with multiple reader devices 120. Each reader device 120 can communicate with each other to share data. Further details regarding the reader devices 120 are described below in connection with FIG. 2A. The reader device 120 can communicate with a local computer system 170 over a communication path 141 using a wired or wireless communication protocol. The local computer system 170 can include a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device, and the wireless communication can include any of a number of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy ( BTLE ), Wi-Fi, etc. The local computer system 170 can communicate with the network 190 via communication path 143, similar to how the reader device 120 can communicate with the network 190 via communication path 142 by wired or wireless communication protocols, as described above. The network 190 can be any of a number of networks, such as private and public networks, local area networks or wide area networks, etc. The trusted computer system 180 can include a server, provide authentication services and protected data storage, and can communicate with the network 190 via communication path 144 using wired or wireless techniques.

Exemplary embodiments of a reader device Figure 2A is a block diagram illustrating one exemplary embodiment of a reader device 120 configured as a smartphone. Here, the reader device 120 can include: a display 122; input components 121; and a processing core 206 including a communication processor 222 coupled to memory 223 and an application processor 224 coupled to memory 225. It can also include: a memory 230; an RF transceiver 228 with an antenna 229; and a power source 226 with a power management module 238. Additionally, the reader device 120 can also include a multi-function transceiver 232, which can communicate with an antenna 234 via Wi-Fi, NFC, Bluetooth, BTLE, and GPS. As can be appreciated by those skilled in the art, these components are electrically and communicatively coupled to form one functional device.

Exemplary Embodiments of a Sensor Control Device Figures 2B and 2C are block diagrams illustrating an exemplary embodiment of a sensor control device 102, which includes an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry), which may have most of the processing power for rendering end result data suitable for display to a user. In Figure 2B, a single semiconductor chip 161 is illustrated, which may be a dedicated application specific integrated circuit (ASIC). Shown within the ASIC 161 are certain higher order functional units, including an analog front end (AFE) 162, power management (or control) circuitry 164, a processor 166, and communications circuitry 168 (which may be implemented as a transmitter, receiver, transceiver, passive circuitry, or otherwise, depending on the communications protocol). In this embodiment, both the AFE 162 and the processor 166 are used as the analyte monitoring circuitry, although in other embodiments, either circuitry may perform the analyte monitoring function. Processor 166 may include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which may be a discrete chip or may be distributed across (or part of) many different chips.

A memory 163 is also included in the ASIC 161, which may be shared by the various functional units present in the ASIC 161 or distributed across two or more of them. The memory 163 may also be a separate chip. The memory 163 may be a volatile and/or non-volatile memory. In this embodiment, the ASIC 161 is coupled to a power source 170, which may be a coin cell battery or the like. The AFE 162 is interfaced with the in vivo analyte sensor 104 and receives measurement data therefrom and outputs said data in digital form to a processor 166, which may process said data to arrive at discrete glucose values and trend values or the like as final results. This data may then be provided to communication circuitry 168 for transmission by antenna 171, for example, to a reader device 120 (not shown), where minimal further processing by a resident software application is required to display said data.

FIG. 2C is similar to FIG. 2B, but includes two discrete semiconductor chips 162 and 174, which may be packaged together or separately. Here, AFE 162 resides on ASIC 161. Processor 166 is integrated on chip 174 with power management circuitry 164 and communications circuitry 168. AFE 162 includes memory 163, and chip 174 includes memory 165, which may be isolated or distributed within. In one exemplary embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communications circuitry 168 is on a separate chip. In another exemplary embodiment, both AFE 162 and communications circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. However, other chip combinations are possible, including three or more chips, each performing the separate functions described above, or sharing one or more functions for fail-safe redundancy.

Exemplary Embodiments of an Assembly Process for a Sensor Control Device According to some embodiments, the components of the sensor control device 102 may be available to a user in multiple packages, with final assembly by the user required prior to delivery to the appropriate user location. Figures 3A-3E show an exemplary embodiment of an assembly process for a sensor control device 102 by a user, which includes preparing the individual components before connecting the components in preparation for delivery of the sensor. In other embodiments, such as those described with respect to Figures 17B-17F, the user may receive the components of the sensor control device 102 and the applicator 150 in a single package. Figures 3F-3G show an exemplary embodiment of delivery of the sensor control device 102 to an appropriate user location by selecting an appropriate delivery location and applying the device 102 to the location.

3A shows a sensor container or tray 810 with a removable lid 812. A user prepares the sensor tray 810 by removing the lid 812, which acts as a sterile barrier to protect the contents of the sensor tray 810 and maintain a sterile internal environment. Removal of the lid 812 exposes a platform 808 positioned within the sensor tray 810, and a plug assembly 207 (partially shown) is disposed within the platform 808 and strategically embedded within the platform 808. The plug assembly 207 includes a sensor module (not shown) and a sharps module (not shown). The sensor module supports a sensor 104 (FIG. 1), and the sharps module supports an associated sharps that are used to assist in transdermal delivery of the sensor 104 subcutaneously to the user during application of the sensor control device 102 (FIG. 1).

3B illustrates the sensor applicator 150 and how a user prepares the sensor applicator 150 for final assembly. The sensor applicator 150 includes a housing 702 sealed at one end with an applicator cap 708. In some embodiments, for example, an O-ring or another type of sealing gasket may seal the interface between the housing 702 and the applicator cap 708. In at least one embodiment, the O-ring or sealing gasket may be molded onto one of the housing 702 and the applicator cap 708. The applicator cap 708 provides a barrier to protect the contents of the sensor applicator 150. In particular, the sensor applicator 150 contains an electronics housing (not shown) that holds the electronic components of the sensor control device 102 (FIG. 1), and the applicator cap 708 may or may not maintain a sterile environment for these electronic components. Preparing the sensor applicator 150 includes the step of disconnecting the housing 702 from the applicator cap 708, which can be accomplished by unscrewing the applicator cap 708 from the housing 702. The applicator cap 708 may then be discarded or set aside.

3C shows a user inserting the sensor applicator 150 into the sensor tray 810. The sensor applicator 150 includes a sheath 704 configured to be received by the platform 808 to temporarily unlock the sheath 704 from the housing 702 and to temporarily unlock the platform 808 from the sensor tray 810. The advancement of the housing 702 into the sensor tray 810 results in a plug assembly 207 (FIG. 3A) disposed within the sensor tray 810 including the sensor and sharps module being coupled to an electronics housing disposed within the sensor applicator 150.

In FIG. 3D, the user removes the sensor applicator 150 from the sensor tray 810 by pulling the housing 702 proximally relative to the sensor tray 810.

Figure 3E shows the bottom and interior of the sensor applicator 150 after removal from the sensor tray 810 (Figures 3A and 3C). The sensor applicator 150 is removed from the sensor tray 810 with the sensor control device 102 fully assembled therein and positioned for delivery to the target monitoring location. As shown, a sharp 2502 extends from the bottom of the sensor control device 102 and supports a portion of the sensor 104 within a hollow or recessed portion thereof. The sharp 2502 is configured to pierce the user's skin, thereby placing the sensor 104 in contact with bodily fluids.

Figures 3F and 3G show an exemplary delivery of the sensor control device 102 to a target monitoring location 221, e.g., the back of a user's arm. Figure 3F shows the user advancing the sensor applicator 150 toward the target monitoring location 221. Upon engaging the skin at the target monitoring location 221, the sheath 704 folds into the housing 702, allowing the sensor control device 102 (Figures 3E and 3G) to be advanced into engagement with the skin. With the aid of the sharp 2502 (Figure 3E), the sensor 104 (Figure 3E) is advanced percutaneously into the patient's skin at the target monitoring location 221.

FIG. 3G shows the user withdrawing the sensor applicator 150 from the target monitoring location 221, with the sensor control device 102 successfully attached to the user's skin. The adhesive patch 105 (FIG. 1) applied to the bottom of the sensor control device 102 adheres to the skin and secures the sensor control device 102 in place. The sharp 2502 (FIG. 3E) is automatically withdrawn once the housing 702 is fully advanced to the target monitoring location 221, leaving the sensor 104 (FIG. 3E) in place to measure the analyte level.

3A-3G and elsewhere herein, system 100 can provide a reduction or elimination of the opportunity for accidental destruction, permanent deformation, or incorrect assembly of applicator components compared to prior art systems. Applicator housing 702 directly engages platform 808 while sheath 704 is unlocked, rather than indirectly through sheath 704, and the relative angle between sheath 704 and housing 702 does not result in destruction or permanent deformation of arms or other components. The likelihood of relatively large forces occurring during assembly (as with conventional devices) is reduced, thereby reducing the opportunity for user assembly errors. Further details regarding embodiments of the applicator, its components, and variations thereof are described in U.S. Patent Publication Nos. 2013/0150691, 2016/0331283, and 2018/0235520, all of which are incorporated by reference in their entirety for all purposes.

Exemplary Embodiments of a Sensor Applicator Device Figure 4A is a side view of an exemplary embodiment of applicator device 150 coupled with a screw cap 708. This is one example of how applicator 150 may be shipped to and received by a user prior to assembly with a sensor by the user. In other embodiments, applicator 150 may be shipped to a user with a sensor and sharps contained therein. Figure 4B is a side perspective view of applicator 150 and cap 708 after decoupling. Figure 4C is a perspective view of an exemplary embodiment of a distal end of applicator device 150 with electronics housing 706 and adhesive patch 105 removed from the positions where they would be held within sensor electronics carrier 710 of sheath 704 when cap 708 is in place.

Exemplary Embodiments of Tray and Sensor Module Assembly FIG. 5 is a proximal perspective view of an exemplary embodiment of a tray 810 with a sterilization lid 812 removably attached, which may be representative of how the package may be shipped to and received by a user in an unassembled state in some embodiments.

FIG. 6A is a proximal perspective cutaway view showing the sensor delivery components in a tray 810, according to some embodiments. A platform 808 is slidably coupled within the tray 810. A desiccant 502 is stationary relative to the tray 810. A sensor module 504 is placed within the tray 810.

6B is a proximal perspective view showing an exemplary embodiment of the sensor module 504 in further detail, where the retention arm extension 1834 of the platform 808 removably secures the sensor module 504 in place. The module 2200 is coupled with the connector 2300, the sharps module 2500, and the sensor (not shown) so that they can be removed one at a time as the sensor module 504 during assembly.

Exemplary embodiment of applicator housing Figure 7A is a side view of an exemplary embodiment of an applicator housing 702 that may include an internal cavity with a support structure for the applicator function. A user may initiate the applicator assembly process by pushing the housing 702 distally, which may subsequently cause delivery of the sensor control device 102, after which the cavity of the housing 702 may act as a sharps receptacle. In this exemplary embodiment, various features are shown, including a housing orientation feature 1302 for orienting the device during assembly and use. The tamper ring groove 1304 may be a recess located around the circumference of the housing 702, distal to the tamper ring protector 1314 and proximal to the tamper ring retainer 1306. The tamper ring groove 1304 may hold a tamper ring, allowing a user to identify whether the device has been tampered with or used. The housing threads 1310 can align with the complementary cap threads and secure the housing 702 to the complementary threads on the cap 708 (FIGS. 4A and 4B) by rotating in a clockwise or counterclockwise direction. The side grip zones 1316 of the housing 702 can provide an outer surface location where a user can grasp to use the housing 702. The grip projections 1318 are slightly raised ridges relative to the side grip zones 1316 that can help to easily remove the housing 702 from the cap 708. The shark teeth 1320 can be a raised section with flat sides located on a clockwise edge for cutting a tamper ring (not shown) and holding the tamper ring in place after the user unscrews the cap 708 and housing 702. In this exemplary embodiment, four shark teeth 1320 are used, but more or less may be used as needed.

7B is a perspective view of the distal end of the housing 702. Here, three housing guide structures (or "guide ribs") 1321 are arranged at an angle of 120° relative to each other and at an angle of 60° relative to the locking structures (or "locking ribs") 1340, of which there are three, also at an angle of 120° relative to each other. Other angular orientations, symmetrical or asymmetrical, and any number of structures 1321 and 1340, one or more, can be used. Here, structures 1321 and 1340 are each configured as planar ribs, although other shapes can be used. Each guide rib 1321 includes a guide edge (also called a "sheath guide rail") 1326 that can extend along the surface of the sheath 704 (e.g., guide rail 1418 described with respect to FIG. 8A). The insertion hard stop 1322 can be a flat, distally facing surface of the housing guide rib 1321 located near the proximal end of the housing guide rib 1321. The insertion hard stop 1322 provides a surface for the sensor electronics carrier travel limiter surface 1420 (FIG. 8B) of the sheath 704 to abut against during use to prevent the sensor electronics carrier travel limiter surface 1420 from moving further in the proximal direction. The carrier interface post 1327 passes through an aperture 1510 (FIG. 9A) of the sensor electronics carrier 710 during assembly. The sensor electronics carrier interface 1328 can be a rounded, distally facing surface of the housing guide rib 1321 that mates with the sensor electronics carrier 710.

7C is a side cross-sectional view of an exemplary embodiment of the housing. In this exemplary embodiment, the side cross-sectional profile of the housing guide rib 1321 and the locking rib 1340 are shown. The locking rib 1340 includes a sheath snap lead-in feature 1330 near the distal end of the locking rib 1340 that flares outward distally from the central axis 1346 of the housing 702. Each sheath snap lead-in feature 1330 bends the detent snap curved portion 1404 of the detent snap 1402 of the sheath 704, as shown in FIG. 8C, inward toward the central axis 1346 as the sheath 704 moves toward the proximal end of the housing 702. Upon passing the distal point of the sheath snap lead-in feature 1330, the detent snap 1402 of the sheath 704 is locked into place within the locking groove 1332. Thus, the detent snap 1402 cannot be easily moved distally by a surface having a plane generally perpendicular to the central axis 1346, shown as the detent snap flat portion 1406 in FIG. 8C.

As the housing 702 moves further proximally toward the skin surface and as the sheath 704 advances toward the distal end of the housing 702, the detent snap 1402 is displaced into the unlocking groove 1334 and the applicator 150 is in an "armed" position, ready for use. As the user applies further force to the proximal end of the housing 702 while pressing the sheath 704 against the skin, the detent snap 1402 passes through the firing detent 1344. This initiates the firing sequence by the release of energy stored in the deflected detent snap 1402, which moves proximally relative to the skin surface toward the sheath stopping ramp 1338, which flares slightly outward relative to the central axis 1346, slowing the movement of the sheath 704 during the firing sequence. The next groove that the detent snap 1402 encounters after the unlock groove 1334 is the final lockout groove 1336 into which the detent snap 1402 enters at the end of the stroke or pressing sequence performed by the user. The final lockout recess 1336 may be a proximally facing surface perpendicular to the central axis 1346 that engages with the detent snap flats 1406 after the detent snap 1402 has passed, securely holding the sheath 704 in place relative to the housing 702, thereby preventing reuse of the device. The insertion hard stop 1322 of the housing guide rib 1321 prevents the sheath 704 from advancing proximally relative to the housing 702 by engaging with the sensor electronics carrier travel limiter surface 1420.

Exemplary Embodiment of Applicator Sheath Figures 8A and 8B are side and perspective views, respectively, illustrating an exemplary embodiment of a sheath 704. In this exemplary embodiment, the sheath 704 can position the sensor control device 102 above the user's skin surface prior to application. The sheath 704 can also include features that aid in holding the sharp in place for proper application of the sensor, determining the force required to apply the sensor, and guiding the sheath 704 relative to the housing 702 during application. A detent snap 1402 is located near the proximal end of the sheath 704 and is further described below with respect to Figure 8C. The sheath 704 can have a generally cylindrical cross-section with a first radius in the proximal section (near the top of the figure) that is shorter than a second radius in the distal section (near the bottom of the figure). Also illustrated are a plurality of detent clearances 1410, three in this exemplary embodiment. The sheath 704 can include one or more detent clearances 1410, each of which can be a cut-out with a space to allow the sheath snap-in feature 1330 to pass distally until the distal surface of the locking rib 1340 contacts the proximal surface of the detent clearance 1410.

The guide rails 1418 are disposed between the sensor electronics carrier travel limiter surface 1420 at the proximal end of the sheath 704 and the cutouts around the locking arms 1412. Each guide rail 1418 can be a channel between two ridges where the guide edge 1326 of the housing guide rib 1321 can slide distally relative to the sheath 704.

The locking arms 1412 can be disposed near the distal end of the sheath 704 and can include an attached distal end and a free proximal end, which can include a locking arm interface 1416. The locking arms 1412 can lock the sensor electronics carrier 710 to the sheath 704 when the locking arm interface 1416 of the locking arms 1412 engages with the locking interface 1502 of the sensor electronics carrier 710. A locking arm strengthening rib 1414 can be disposed near a central position of each locking arm 1412 and can act as a strengthening point for a weak point of the locking arms 1412 to prevent the locking arms 1412 from bending excessively or breaking.

The detent snap reinforcement feature 1422 can be located along the distal section of the detent snap 1402 to provide reinforcement to the detent snap 1402. The alignment notch 1424 can be a cutout near the distal end of the sheath 704 that provides an opening for user alignment with the sheath orientation feature of the platform 808. The reinforcement rib 1426 can include a buttress, here triangular shaped, that provides support for the detent base 1436. The housing guide rail clearance 1428 can be a cutout for sliding the distal surface of the housing guide rib 1321 during use.

8C is a close-up perspective view of an exemplary embodiment of the detent snap 1402 of the sheath 704. The detent snap 1402 can include a detent snap bridge 1408 disposed near or at its proximal end. The detent snap 1402 can also include a detent snap flat portion 1406 distal to the detent snap bridge 1408. The outer surface of the detent snap bridge 1408 can include a detent snap curved portion 1404, which is a rounded surface that allows for easier movement of the detent snap bridge 1408 over an inner surface of the housing 702, such as the locking rib 1340.

FIG. 8D is a side view of an exemplary embodiment of the sheath 704. Here, the alignment notch 1424 can be relatively close to the detent clearance 1410. The detent clearance 1410 is in a relatively proximal location on the distal portion of the sheath 704.

8E is an end view of an exemplary embodiment of the proximal end of the sheath 704. Here, the rear wall 1446 of the guide rail can provide a channel for slidably coupling with the housing guide rib 1321 of the housing 702. The sheath rotation limiter 1448 can be a notch that reduces or prevents rotation of the sheath 704.

8F is a perspective view of an exemplary embodiment of a compressible distal end 1450 that can be attached to and detached from the sheath 704 of the applicator 150. In a general sense, the embodiments described herein operate by flattening and stretching the skin surface at a predetermined location for insertion of a sensor. Additionally, the embodiments described herein can be used in other apparel applications, such as, for example, transdermal drug delivery, needle injections, suturing to close wounds, implanting devices, applying adhesive surfaces to the skin, and similar applications.

By way of background, one of ordinary skill in the art will appreciate that skin is a highly anisotropic tissue from a biomechanical standpoint, and varies greatly between individuals. This may affect, for example, the rate of drug diffusion, the ability to penetrate the skin with a sharp, or the degree to which communication can be achieved between the underlying tissue and the surrounding environment with respect to the insertion of a sensor into the body at a sharp-guided insertion site.

In particular, the embodiments described herein are directed to reducing the anisotropy of the skin in a given area by flattening and tensioning the skin, thereby improving the application described above. After the skin is smoothed (e.g., flattened to remove wrinkles), it can be mated with a similarly shaped (e.g., flat) round adhesive pad of the sensor control unit to form a contact interface with a more consistent surface area. The closer the surface profile of the skin is to the profile specifications of the designed device surface (or the designed contact area for drug delivery, for example), the more consistent contact (or drug dispensing) can be achieved. This can also be advantageous for wearable adhesives by creating a continuum of adhesive-skin contact in a given area without wrinkles. Other advantages include: (1) increased wear time for devices that rely on adhesion to the skin for functionality; and (2) a more predictable skin contact area, improving dosing in transdermal drug/pharmaceutical delivery.

Furthermore, the combination of flattening and tensioning of the skin (e.g., as a result of tissue compression) can reduce the viscoelasticity of the skin and increase its stiffness, thereby increasing the success of placement and function of sensors that rely on sharps.

With regard to sensor insertion, puncture trauma may contribute to early signal aberration (ESA) of the sensor and may be mitigated by flattening and pulling the skin to be firm. Known methods for minimizing puncture trauma include: (1) reducing the size of the introducer; or (2) limiting the length of the needle inserted into the body. However, these known methods may reduce the success rate of insertion due to skin compliance. For example, when the sharp tip touches the skin, the skin deforms inward toward the body before the tip penetrates the skin. This reduction is also called "skin tenting." If the sharp does not have sufficient stiffness, due to a relatively small cross-sectional area and/or not being long enough, the sharp may not be able to form a large enough insertion point or deflect to a desired location to properly position the sensor through the skin. The degree of skin tenting can vary between subjects and even within a single subject, i.e., the distance between the sharp and the skin surface can vary between each instance of insertion. Reducing this variability by tensioning and flattening the skin can result in a more accurately functioning and consistent sensor insertion mechanism.

Referring to FIG. 8F, a perspective view of an exemplary embodiment of the compressible distal tip 1450 of the applicator 150 is shown. According to some embodiments, the compressible distal tip 1450 can be manufactured from an elastomeric material. In other embodiments, the compressible distal tip 1450 can be made of metal, plastic, composite legs or springs, or combinations thereof.

In some embodiments, the compressible distal end 1450 can be detachable from the applicator 150 and can be used with a variety of other similar or dissimilar applicators or medical devices. In other embodiments, the compressible distal end 1450 can be manufactured as part of the sheath 704. In still other embodiments, the compressible distal end 1450 can be attached to other portions of the applicator 150 (e.g., a sensor electronics carrier) or can be used as a separate stand-alone device. Additionally, although the compressible distal end 1450 is illustrated in FIGS. 8F and 8G as having a continuous ring-like geometry, other configurations are available. For example, FIGS. 8H-8K are cross-sectional views illustrating various exemplary compressible distal ends having an octagonal geometry 1451 (FIG. 8H), a star-shaped geometry 1452 (FIG. 8I), a discontinuous ring-like geometry 1453 (FIG. 8J), and a discontinuous rectangular geometry 1454 (FIG. 8K). With reference to Figures 8J-8K, a compressible distal end having a discontinuous geometry will have multiple points or areas of contact with a given area of the skin. One of ordinary skill in the art will appreciate that other geometries are possible and are fully within the scope of the present disclosure.

8L and 8M are perspective and cross-sectional views, respectively, of an applicator 150 having a compressible distal end 1450. As shown in FIGS. 8L and 8M, the applicator 150 can also include an applicator housing 702, a sheath 704 to which the compressible distal end 1450 is attached, a sharps 2502, and a sensor 104.

In operation, according to some embodiments, the compressible distal end 1450 of the applicator is first positioned on the skin surface of the subject. The subject then applies a force, e.g., in a distal direction, to the applicator, which causes the compressible distal end 1450 to stretch and flatten a portion of the skin surface underneath. In some embodiments, for example, the compressible distal end 1450 can be comprised of an elastomeric material and can be biased radially inward. In other embodiments, the compressible distal end 1450 can be biased radially outward. The force on the applicator can displace an edge portion of the compressible distal end 1450 in contact with the skin surface in a radially outward direction, which creates a radially outward force on the portion of the skin surface underneath the applicator, stretching and flattening the skin surface.

Further, according to some embodiments, a medical device, such as a sensor control unit, is moved from a first position within the applicator to a second position adjacent to the skin surface by applying a force to the applicator. According to an aspect of some embodiments, the compressible distal end 1450 can be unloaded in a first position (e.g., before a force is applied to the applicator) and loaded in a second position (e.g., after a force is applied to the applicator). The medical device is then applied to the stretched and flattened portion of the skin surface beneath the compressible distal end 1450. According to some embodiments, applying the medical device can include placing an adhesive patch 105 of the sensor control unit 102 on the skin surface and/or positioning at least a portion of an analyte sensor beneath the skin surface. The analyte sensor can be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject. In yet other embodiments, applying the medical device can include placing a drug-loaded patch onto the skin surface. One of ordinary skill in the art will appreciate that the compressible distal end may be utilized with any of the medical applications discussed above and is not intended to be limited to use in an applicator for insertion of an analyte sensor.

Exemplary Embodiment of Sensor Electronics Carrier FIG. 9A is a proximal perspective view of an exemplary embodiment of a sensor electronics carrier 710 that can hold the sensor electronics within the applicator 150. It can also hold a sharps carrier 1102 with a sharps module 2500. In this exemplary embodiment, the sensor electronics carrier 710 has a generally hollow round flat cylindrical shape and can include one or more (e.g., three) deflectable sharps carrier locking arms 1524 that extend proximally from a proximal surface surrounding a centrally located spring alignment ridge 1516 for maintaining alignment of the springs 1104. Each locking arm 1524 has a detent or retention feature 1526 located at or near its proximal end. A shock lock 1534 can be a tab located on the outer periphery of the sensor electronics carrier 710 that extends outwardly to lock the sensor electronics carrier 710 for added safety prior to firing. The rotation limiter 1506 may be a relatively short proximally extending protrusion on the proximal surface of the sensor electronics carrier 710 that limits rotation of the carrier 710. The sharps carrier locking arm 1524 may mate with the sharps carrier 1102 as described below with reference to Figures 10 and 11.

9B is a distal perspective view of the sensor electronics carrier 710, where one or more (e.g., three) sensor electronics retention spring arms 1518 are biased vertically toward the position shown and include detents 1519 that can pass through a distal surface of the electronics housing 706 of the device 102 when stored in a recess or cavity 1521. In certain embodiments, after attaching the sensor control device 102 to the skin with the applicator 150, the user pulls the applicator 150 in a proximal direction, i.e., away from the skin. The adhesive forces hold the sensor control device 102 on the skin and overcome the lateral force applied by the spring arms 1518. As a result, the spring arms 1518 deflect radially outward, disengaging the detents 1519 from the sensor control device 102 and thereby releasing the sensor control device 102 from the applicator 150.

10 and 11 are proximal perspective and side cross-sectional views, respectively, of an exemplary embodiment of a sharps carrier 1102. The sharps carrier 1102 can grip a sharps module 2500 and hold it within the applicator 150. Near the distal end of the sharps carrier 1102 can be an anti-rotation slot 1608 that prevents the sharps carrier 1102 from rotating when positioned within the central area of the sharps carrier locking arm 1524 (as shown in FIG. 9A). The anti-rotation slot 1608 can be located between multiple sections of the sharps carrier base chamfer 1610 to ensure that the sharps carrier 1102 is fully withdrawn through the sheath 704 when the sharps carrier 1102 is withdrawn at the end of the deployment procedure.

As shown in FIG. 11, the sharps retaining arms 1618 can be positioned about a central axis within the sharps carrier 1102 and can include a sharps retaining clip 1620 at a distal end of each arm 1618. The sharps retaining clip 1620 can have a proximal surface that can be generally perpendicular to the central axis and can abut a distally facing surface of the sharps hub 2516 (FIG. 17A).

Exemplary embodiment of a sensor module Figures 12A and 12B are top and bottom perspective views, respectively, of an exemplary embodiment of a sensor module 504. The module 504 can hold a connector 2300 (Figures 13A and 13B) and a sensor 104 (Figure 14). The module 504 can be securely coupled to an electronics housing 706. One or more deflectable arms or module snaps 2202 can snap into corresponding features 2010 of the housing 706. The sharps slots 2208 can provide a place for the sharps tip 2502 to pass through and for the sharps shaft 2504 to temporarily reside. The sensor ledge 2212 can define the position of the sensor in the horizontal plane, preventing the sensor from lifting the connector 2300 off the post and keeping the sensor 104 parallel to the plane of the connector seal. This can also define the sensor bend geometry and minimum bend radius. This can limit vertical sensor travel to prevent the tower from protruding above the electronics housing surface and define the length of the sensor tail below the patch surface. The sensor walls 2216 can constrain the sensor and define the bending geometry and minimum bend radius of the sensor.

13A and 13B are perspective views of an exemplary embodiment of a connector 2300 in an open and closed state, respectively. The connector 2300 can be made of silicone rubber encapsulating a corresponding carbon-impregnated polymer module that serves as a conductive contact 2302 between the sensor 104 and the electrical circuit contacts for the electronics in the housing 706. The connector can also serve as a moisture barrier for the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and application to the user's skin. Multiple sealing surfaces 2304 can provide a water-tight seal for the electrical and sensor contacts. One or more hinges 2308 can connect the two distal and proximal portions of the connector 2300.

14 is a perspective view of an exemplary embodiment of the sensor 104. The neck 2406 can be a zone where the sensor can be folded, for example, 90°. The membrane on the tail 2408 can cover the active analyte sensing element of the sensor 104. The tail 2408 can be the portion of the sensor 104 that is under the user's skin after insertion. The flag 2404 can include contacts and a sealing surface. The bias tower 2412 can be a tab that biases the tail 2408 into the sharps slot 2208. The bias fulcrum 2414 can be an outgrowth of the bias tower 2412 that contacts the inner surface of the needle to bias the tail into the slot. The bias adjuster 2416 can reduce local bending of the tail connection and prevent damage to the sensor traces. The contact 2418 can electrically couple the active portion of the sensor to the connector 2300. The service loop 2420 can move the electrical path 90° from the vertical to engage the sensor ledge 2212 (FIG. 12B).

15A and 15B are bottom and top perspective views, respectively, of an exemplary embodiment of a sensor module assembly including a sensor module 504, a connector 2300, and a sensor 104. According to one aspect of the above-described embodiment, during or after insertion, the sensor 104 can be subjected to an axial force that pushes the sensor 104 proximally up into the sensor module 504, as shown by force F1 in FIG. 15A. According to some embodiments, this can apply a counter force F2 to the neck 2406 of the sensor 104, which in turn can transmit a counter force F3 to the service loop 2420 of the sensor 104. In some embodiments, for example, the axial force F1 can occur as a result of a sensor insertion mechanism designed to push the sensor against tissue, a sharps extraction mechanism during insertion, or a physiological response generated by tissue surrounding the sensor 104 (e.g., after insertion).

16A and 16B are partial close-up views of an exemplary embodiment of a sensor module assembly having a particular axial stiffening feature. In general, the embodiments described herein are directed to mitigating the effects of axial forces on the sensor as a result of insertion and/or withdrawal mechanisms or due to physiological responses to the sensor within the body. As can be seen in FIGS. 16A and 16B, according to one aspect of these embodiments, the sensor 3104 comprises a proximal portion having a hook-like feature 3106 configured to engage with a catch-like feature 3506 of the sensor module 3504. In some embodiments, the sensor module 3504 can also include a clearance area 3508 that allows a distal portion of the sensor 3104 to swing back during assembly to allow for assembly of the hook-like feature 3106 of the sensor 3104 to and within the catch-like feature 3506 of the sensor module 3504.

According to another aspect of the embodiment, the hook-like feature 3106 and the catch-like feature 3506 operate as follows: The sensor 3104 includes a proximal sensor portion coupled to the sensor module 3504 as described above, and a distal sensor portion positioned below the skin surface in contact with bodily fluids. As seen in FIGS. 16A and 16B, the proximal sensor portion includes the hook-like feature 3106 adjacent to the catch-like feature 3506 of the sensor module 3504. During or after sensor insertion, one or more forces are applied in a proximal direction along the longitudinal axis of the sensor 3104. In response to the one or more forces, the hook-like feature 3106 engages the catch-like feature 3506, thereby preventing proximal displacement of the sensor 3104 along the longitudinal axis.

According to another aspect of the above embodiment, the sensor 3104 can be assembled with the sensor module 3504 as follows: The sensor 3104 is loaded into the sensor module 3504 by displacing the proximal sensor portion laterally to bring the hook feature 3106 proximal to the catch feature 3506 of the sensor module 3504. More specifically, displacing the proximal sensor portion laterally moves the proximal sensor portion into the clearance area 3508 of the sensor module 3504.

16A and 16B illustrate the hook feature 3106 as part of the sensor 3104 and the catch feature 3506 as part of the sensor module 3504, those skilled in the art will appreciate that the hook feature 3106 could alternatively be part of the sensor module 3504, and similarly, the catch feature 3506 could alternatively be part of the sensor 3106. Similarly, those skilled in the art will appreciate that other mechanisms (e.g., detents, latches, fasteners, screws, etc.) implemented on the sensor 3104 and sensor module 3504 to prevent axial displacement of the sensor 3104 are possible and within the scope of the present disclosure.

Exemplary embodiments of a sharps module Figure 17A is a perspective view of an exemplary embodiment of a sharps module 2500 prior to assembly into the sensor module 504 (Figure 6B). The sharps 2502 can include a distal tip 2506 that can pierce the skin while supporting the sensor tail within a hollow or recess in the sharps shaft 2504 to contact the active surface of the sensor tail with bodily fluids. The hub push cylinder 2508 can provide a surface for pushing the sharps carrier during insertion. The hub mini cylinder 2512 can provide space for an extension of the sharps hub contact surface 1622 (Figure 11). The hub snap tab placement cylinder 2514 can provide a distal facing surface for the hub snap tab 2516 for abutting the sharps hub contact surface 1622. The hub snap tabs 2516 may include conical surfaces that open the clips 1620 during installation of the sharps module 2500. Further details regarding embodiments of the sharps modules, sharps, their components, and variations thereof are described in U.S. Patent Publication No. 2014/0171771, which is incorporated by reference in its entirety and for all purposes.

Figures 17B, 17C, and 17D show example embodiments of plastic sharps modules. By way of background, according to one aspect of these embodiments, plastic sharps can be advantageous in at least two ways.

First, compared to metal sharps, plastic sharps can reduce trauma to tissue during the insertion process into the skin. Due to the manufacturing process, e.g., chemical etching and mechanical molding, metal sharps typically feature sharp edges and burrs that can cause trauma to tissue at the insertion site. In contrast, plastic sharps can be designed with rounded edges and smooth finishes to reduce trauma when positioning the sharp through tissue. Moreover, one skilled in the art will appreciate that reduced trauma during the insertion process can lead to reduced ESA and improved accuracy of analyte level readings immediately after insertion.

Second, plastic sharps can simplify the manufacturing and assembly process of the applicator. As with the previously described embodiments, a particular applicator is provided to the user in two parts: (1) an applicator that contains the sharps and sensor electronics in a sensor control unit; and (2) a sensor container, which requires the user to assemble the sensor into the sensor control unit. One reason for this two-part assembly is to allow e-beam sterilization of the sensor to be performed separately from the applicator that contains the metallic sharps and sensor electronics. Metallic sharps, e.g., stainless steel sharps, have a higher density than sharps made of polymeric or plastic materials. As a result, e-beam scattering from an e-beam impinging on a metallic sharp can damage the sensor electronics of the sensor control unit. By utilizing a plastic sharps, e.g., a sharps made from a polymeric material, and additional shielding features to keep the electron beam path away from the sensor electronics, the applicator and sensor can be packaged sterile in a single package, thereby reducing manufacturing costs and simplifying the assembly process for the user.

17B, a perspective view of an exemplary embodiment of a plastic sharps module 2550 is shown, which may include a hub 2562 coupled to a proximal end of the sharps, a sharps shaft 2554, a sharps distal tip 2556 configured to pierce a skin surface, and a sensor channel 2558 configured to receive at least a portion of an analyte sensor 104. Any or all of the components of the sharps module 2550 may be constructed of a plastic material, such as, for example, a thermoplastic material, a liquid crystal polymer (LCP), or a similar polymeric material. In some embodiments, for example, the sharps module may include a polyetheretherketone material. In other embodiments, a silicone or other lubricant may be applied to the exterior surface of the sharps module and/or incorporated into the polymeric material of the sharps module to reduce trauma caused during the insertion process. Additionally, to reduce trauma during insertion, one or more of the sharps shaft 2554, the sharps distal tip 2556, and the alignment features 2568 (described below) may include filleted and/or smoothed edges.

In some embodiments, when assembled, the distal end of the analyte sensor can be proximal to the sharps distal tip 2556. In other embodiments, the distal end of the analyte sensor and the sharps distal tip 2556 are in the same location.

According to another aspect of some embodiments, the plastic sharps module 2550 can also include an alignment feature 2568 configured to prevent rotational movement of the sharps module 2550 along the vertical axis 2545 during the insertion process, where the alignment feature 2568 can be positioned along a proximal portion of the sharps shaft 2554.

17C and 17D are side and perspective views, respectively, of another exemplary embodiment of a plastic sharps module 2570. Similar to the embodiment described with respect to FIG. 17B, the plastic sharps module 2570 can include a hub 2582 coupled to a proximal end of the sharps, a sharps shaft 2574, a sharps distal tip 2576 configured to pierce a skin surface, and a sensor channel 2578 configured to receive at least a portion of an analyte sensor 104. Any or all of the components of the sharps module 2570 can be constructed of a plastic material, such as, for example, a thermoplastic material, LCP, or similar polymeric material. In some embodiments, a silicone or other lubricant can be applied to the outer surface of the sharps module 2570 and/or incorporated into the polymeric material of the sharps module 2570 to reduce trauma caused during the insertion process.

According to some embodiments, the sharps shaft 2574 can include a distal portion 2577 that terminates at a distal tip 2576 at which at least a portion of the sensor channel 2578 is disposed. The sharps shaft 2574 can also have a proximal portion 2575 adjacent the distal portion 2577, where the proximal portion 2575 is solid, partially solid, or hollow and is coupled to a hub 2582. Although FIGS. 17C and 17D illustrate the sensor channel 2578 as being disposed only within the distal portion 2577, one skilled in the art will appreciate that the sensor channel 2578 can also extend through the majority or along the entire length of the sharps shaft 2574 (including through at least a portion of the proximal portion 2575) (e.g., as shown in FIG. 17B). Additionally, according to another aspect of some embodiments, at least a portion of the proximal portion 2575 can have a wall thickness greater than the wall thickness of the distal portion 2577, which can reduce the likelihood of the sharps bending due to stress during the insertion process. According to another aspect of some embodiments, the plastic sharps module 2570 can have one or more ribs (not shown) adjacent the sharps hub portion 2582, which can reduce the compressive load around the hub 2582 and can reduce bending due to stress of the sharps during the insertion process.

17E is a cross-sectional view of an exemplary embodiment of an applicator 150 with a plastic sharps module during an electron beam sterilization process. As indicated by rectangular area A, the electron beam is focused on the sensor 104 and the plastic sharps module 2550 of the applicator 150 during the sterilization process. According to some embodiments, a cap 708 is secured to the applicator housing 702, thereby sealing the sensor control device 102 within the applicator 150. During the sterilization process, as indicated by the diagonal arrows emanating from the plastic sharps module 2550, the electron beam scatters in this direction, and the path of the sensor electronics 160 is reduced due to the use of the plastic sharps module 2550 instead of a metal sharps. Although FIG. 17E illustrates a focused electron beam sterilization process, one skilled in the art will recognize that the applicator embodiment with a plastic sharps module can also be utilized during an unfocused electron beam sterilization process.

17F is a flow chart of an exemplary embodiment of a method 1100 for sterilizing an applicator assembly according to the embodiments described above. In step 1105, the sensor control device 102 is loaded into the applicator 150. The sensor control device 102 can include various components including: an electronics housing; a printed circuit board positioned within the electronics housing and containing processing circuitry; an analyte sensor extending from the bottom of the electronics housing; and a plastic sharps module having a plastic sharps extending through the electronics housing. According to some embodiments, the plastic sharps can also receive a portion of the analyte sensor extending from the bottom of the electronics housing. As described above, in step 1110, the sensor control device 102 is sealed within the applicator 150 by securing the cap 708 to the applicator housing 702 of the applicator 150. In step 1115, the analyte sensor 104 and plastic sharps 2550 are sterilized by radiation while the sensor control device 102 remains positioned within the applicator 150.

According to some embodiments, the sensor control device 102 can also include at least one shield positioned within the electronics housing, the one or more shields configured to shield the processing circuitry from radiation during the sterilization process. In some embodiments, the shield can include a magnet that generates a static magnetic field to deflect radiation away from the processing circuitry. In this manner, the combination of the plastic sharps module and the magnetic shield/deflector can work in concert to protect the sensor electronics from radiation during the sterilization process.

Another exemplary embodiment of a sharps designed to reduce trauma during the sensor insertion and extraction process is now described. More specifically, certain embodiments described herein are directed to sharps constructed from a metallic material (e.g., stainless steel) and manufactured by a coining process. According to one aspect of the above embodiment, the coined sharps can be characterized as having one sharps tip and all other edges constructed with rounded edges. As discussed above, metallic sharps manufactured by chemical etching and mechanical forming processes can result in sharp edges and unintended hook features. For example, FIG. 17G is a photograph of a metallic sharps 2502 manufactured by chemical etching and mechanical forming processes. As can be seen in FIG. 17G, the metallic sharps 2502 include a sharps distal tip 2506 with a hook feature. These and other unintended transition features can lead to increased trauma to tissue during the sensor insertion and extraction process. In contrast, FIG. 17H is a photograph of a coined sharp 2602, a metal sharp produced by a coining process. As can be seen in FIG. 17H, the coined sharp 2602 also includes a sharp distal tip 2606. However, the coined sharp 2602 includes only smooth, rounded edges without any unintended sharp edges or transitions.

Similar to the sharps embodiments described above, the coined sharps 2602 embodiments described herein can also be assembled into a sharps module having a sharp portion and a hub portion. Similarly, the sharp portion comprises: a sharps shaft; a sharps proximal end coupled to a distal end of the hub portion; and a sharps distal tip configured to penetrate a skin surface. According to one aspect of the above embodiment, one or all of the sharp portion, sharps shaft, and sharps distal tip of the coined sharps 2602 can comprise one or more rounded edges.

Furthermore, one of ordinary skill in the art will appreciate that the coined sharps 2602 embodiments described herein may also be used with any of the sensors described herein, including in vivo analyte sensors configured to measure analyte levels in a subject's bodily fluid. For example, in some embodiments, the coined sharps 2602 may include a sensor channel (not shown) configured to receive at least a portion of an analyte sensor. Similarly, in some embodiments of a sharps module assembly utilizing a coined sharps 2602, the distal end of the analyte sensor may be proximal to the sharps distal tip 2606. In other embodiments, the distal end of the analyte sensor and the sharps distal tip 2606 are co-located.

We now describe another exemplary embodiment of a sharps designed to reduce trauma during the sensor insertion process. Referring again to FIG. 17A, an exemplary embodiment of a sharps module 2500 (shown without an analyte sensor) is illustrated, which includes a sharps 2502 with a sensor channel having a U-shaped geometry configured to receive at least a portion of an analyte sensor, and a distal tip 2506 configured to penetrate the skin surface during the sensor insertion process.

In certain embodiments, the sharps module can include a sharps having a distal tip with an offset geometry configured to form a smaller opening in the skin compared to other sharps (e.g., sharps 2502 shown in FIG. 17A). Turning to FIG. 17I, a perspective view of an exemplary embodiment of a sharps module 2620 (with an analyte sensor 104) having an offset tip portion is shown. Similar to the sharps modules described above, the sharps module 2620 can include: a sharps shaft 2624 coupled at a proximal end to a hub 2632; a sensor channel 2628 configured to receive at least a portion of the analyte sensor 104; and a distal tip 2626 configured to pierce the skin surface during the sensor insertion process.

According to one aspect of the embodiment, the one or more side walls 2629 forming the sensor channel 2628 are disposed along the sharps shaft 2624 at a predetermined distance Dsc from the distal tip 2626. In certain embodiments, the predetermined distance Dsc can be between 1 mm and 8 mm. In other embodiments, the predetermined distance Dsc can be between 2 mm and 5 mm. One skilled in the art will recognize that other predetermined distances Dsc are available and are fully within the scope of the present disclosure. In other words, according to some embodiments, the sensor channel 2628 is in a spaced apart relationship to the distal tip 2626. In this regard, the distal tip 2626 has a reduced cross-sectional footprint, for example, as compared to the distal tip 2506 of the sharps module 2500, whose sensor channel is adjacent to the distal tip 2506. According to another aspect of the embodiment, the distal tip 2626 terminates in an offset tip portion 2627 configured to prevent the sensor tip 2408 from being damaged during insertion and to form a small opening in the skin. In some embodiments, the offset tip portion 2627 can be a separate element coupled to the distal end of the sharps shaft 2624. In other embodiments, the offset tip portion 2627 can be formed from a portion of the distal tip 2506 or the sharps shaft 2624. During insertion, as the sharps moves into the skin surface, the offset tip portion 2627 can laterally pull and spread the skin surrounding the skin opening without further cutting the skin tissue. In this regard, relatively little trauma occurs during the sensor insertion process.

17J, a perspective view of another exemplary embodiment of a sharps module 2640 (with an analyte sensor 104) having an offset tip portion is shown. Similar to the embodiment described above, the sharps module 2640 can include: a sharps shaft 2644 coupled at a proximal end to a hub 2652; a sensor channel 2648 configured to receive at least a portion of the analyte sensor 104; and a distal tip 2646 configured to pierce the skin surface during the sensor insertion process. According to one aspect of the above embodiment, the sensor channel 2648 can include a first sidewall 2649a and a second sidewall 2649b, where the first sidewall 2649a extends to the distal tip 2646 and the first sidewall 2649a terminates to form an offset tip portion 2647, and the second sidewall 2649b is disposed a predetermined distance along the sharps shaft 2644 from the distal tip 2646 and terminates proximal to the first sidewall 2649a. Those skilled in the art will appreciate that in other embodiments, the second sidewall 2649b can extend to the distal tip 2646 instead of the first sidewall 2649a to form the offset tip portion 2647. Additionally, the offset tip portion 2647 can be formed from a third or fourth sidewall (not shown), and such geometries are fully within the scope of the present disclosure.

With respect to the embodiments of the sharps and sharps modules described herein, one of ordinary skill in the art will recognize that any or all of the components may include a metallic material, such as stainless steel, or a plastic material, such as liquid crystal polymer. Furthermore, one of ordinary skill in the art will understand that any of the embodiments of the sharps and/or sharps modules described herein may be used or combined with any of the sensors, sensor modules, sensor electronics carriers, sheaths, applicator devices, or other analyte monitoring systems described herein.

Exemplary Embodiment of Powered Applicator Figures 18A and 18B are cross-sectional and exploded views, respectively, of an exemplary embodiment of a powered applicator 4150 for inserting an analyte sensor into a subject's body. According to one aspect of the embodiment, the housing 4702 of the powered applicator 4150 acts as a trigger that releases and activates the drive spring 4606 under light pressure, pushing the sensor electronics carrier 4710 downward to insert the sharp and analyte sensor into the subject's body. When the subject pulls the applicator 4150 away from the skin, the extraction spring 4604 is activated, extracting the sharp from the subject. According to certain aspects of the embodiment, the powered applicator 4150 can provide a faster and more controlled insertion rate compared to applicators that rely on manual force for insertion. A powered applicator 4150 has the further advantage of improving insertion success rates and reducing insertion site trauma as compared to applicators that rely on manual force for insertion.

18A and 18B, various components of the powered applicator 4150 will now be described. As can be seen in FIG. 18A as a cross-sectional view of the assembled powered applicator 4150 (initial state) and in FIG. 18B as an exploded view, the powered applicator 4150 can include the following components: housing 4702, sharps carrier 4602, extraction spring 4604, sheath 4704, firing pin 4705, drive spring 4606, sensor electronics carrier 4710. Additionally, although not shown, the powered applicator 4150 can also include any of the sensor control unit, analyte sensor, and sharps embodiments described herein or in other publications incorporated by reference into this application.

Figures 19A-19L show various views of an exemplary embodiment of a powered applicator 4150 during various stages of deployment.

19A is a cross-sectional view of the powered applicator 4150 in an initial state, where the distal end of the applicator 4150 is ready for positioning on the skin surface of a subject. In this initial state, the drive spring 4606 and the extraction spring 4604 are each in a preloaded state. The drive spring 4606 includes a first end coupled to the firing pin 4705 and a second end coupled to the sensor electronics carrier 4710. The extraction spring 4604 includes a first end coupled to the sharps carrier 4602 and a second end coupled to the sensor electronics carrier 4710. As best seen in FIG. 19A, in the initial state, the sensor electronics carrier 4710 and the sharps carrier 4602 are in a first position within the applicator 4150 in a spaced apart relationship to the skin surface.

According to certain aspects of the above embodiment, in an initial state, the sensor electronics carrier 4710 is coupled to the sheath 4704 by one or more latch-tab structures. FIG. 19B shows a perspective view of the sheath 4704 with one or more sheath stubs 4706. FIG. 19C shows a perspective view of the sensor electronics carrier 4710 with one or more corresponding sensor electronics carrier latches 4603. In an initial state, as best seen in FIG. 19A, each of the one or more sensor electronics carrier latches 4603 engages with a corresponding sheath stub 4706. Although FIGS. 19B and 19C illustrate three sheath stubs 4706 and three sensor electronics carrier latches 4603, one skilled in the art will understand that fewer or more latch-tab structures can be utilized. These embodiments are fully within the scope of the present disclosure.

19D is a cross-sectional view of the powered applicator 4150 in a fired state, where a force F1 is applied to the applicator 4150 in a distal direction (as indicated by the dark arrow). According to one aspect of the embodiment, application of force F1 causes the firing pin 4705 to move distally along the sheath 4704, which then disengages the sheath stub 4706 from the sensor electronics carrier latch 4603 (as indicated by the white arrow). Disengaging the sheath stub 4706 from the sensor electronics carrier latch 4603 causes the drive spring 4606 to extend distally, thereby "firing" the applicator 4150. As the drive spring 4606 extends distally, the sensor electronics carrier 4710 and the sharps carrier 4602 are displaced distally, again to a second position adjacent the skin surface.

In some embodiments, applying force F1 prior to disengagement of sheath stub 4706 can increase the load on drive spring 4606 by further compressing drive spring 4606.

According to one aspect of the above embodiment, the "cylinder-on-cylinder" design of the sheath 4704 and firing pin 4705 can provide stable simultaneous release of all three sensor electronics carrier latches 4603. Additionally, in some embodiments, certain features can provide enhanced stability during displacement of the sensor electronics carrier 4710 and sharps carrier 4602 from the first position to the second position. As can be seen, for example, in FIG. 19E, the sensor electronics carrier 4710 can include one or more sensor electronics carrier tabs 4605 configured to move distally along one or more sheath rails 4707 of the sheath 4704. As can further be seen in FIG. 19F, in some embodiments, the sensor electronics carrier 4710 can include one or more sensor electronics carrier bumpers 4607, each of which can be biased against the inner surface of the sheath 4704 during displacement of the sensor electronics carrier 4710 and the sharps carrier 4602 from the first position to the second position.

19G is a cross-sectional view of the powered applicator 4150 in the insertion state, with force F1 still being applied to the applicator 4150 in a distal direction (as indicated by the dark arrow). Force F1 allows the subject to hold the applicator 4150 against the skin during insertion. During the insertion state, the sharps and a portion of the analyte sensor (not shown) are positioned below the skin surface and in contact with the subject's bodily fluids. Furthermore, the sharps extraction process is not initiated at this stage. As can be best seen in FIG. 19I, the sensor electronics carrier locking arm 4524 remains restrained by the sheath 4704, thereby preventing the sharps carrier 4602 (and sharps) from being extracted.

According to another aspect of the above embodiment, during the insertion state, when the sensor electronics carrier 4710 reaches the second position, the sensor electronics carrier 4710 and a distal portion of a sensor control unit (not shown) coupled to the sensor electronics carrier 4710 rest in contact with the skin surface. In some embodiments, the distal portion of the sensor control unit can be an adhesive surface.

Further, according to some embodiments, as best seen in FIG. 19H, during the inserted state, the sensor electronics carrier tab 4605 positioned within the sheath rail 4707 is displaced to a second position, but is still positioned above the bottom of the applicator 4150, as indicated by the distance R.

19J is a cross-sectional view of the powered applicator 4150 in a sharps extraction state. According to one aspect of the embodiment, after completing the insertion state, the subject applies a force F2 to the applicator 4150, this time in a proximal direction. Force F2 allows the subject to pull or remove the applicator 4150 away from the skin surface. By applying force F2, the extraction spring 4604 displaces the sharps carrier 4602 from a second position (e.g., adjacent the skin surface) to a third position within the applicator 4150, thereby extracting the sharps from the skin surface.

More specifically, application of force F2 causes the drive spring 4606 to displace the sensor electronics carrier 4710 toward a bottom portion of the applicator 4150. As can be seen in FIG. 19J, a portion of the sensor electronics carrier 4710 protrudes below the bottom of the sheath 4704. Similarly, as shown in FIG. 19K, during the sharps withdrawal state, the sensor electronics carrier tab 4605 is flush with the bottom of the sheath slot 4707.

According to another aspect of the above embodiment, continued application of force F2 positions each of the sensor electronics carrier lock arms 4524 into the sheath notch 4708, as best seen in FIG. 19L. As a result, the sensor electronics carrier lock arms 4524, biased in a radially outward direction, can extend in a radially outward direction through the sheath notch 4708. The sensor electronics carrier lock arms 4524 then disengage from and release the sharp carrier 4602, allowing the extraction spring 4604 to freely extend proximally. As the extraction spring 4604 extends proximally, the sharp carrier 4602 is displaced to a third position (e.g., above the sheath 4704) within the applicator 4150, thereby extracting the sharp from the skin surface.

Note that while compression springs are illustrated in FIGS. 18A-18B and 19A-19L for the drive spring 4606 and the sharps extraction spring 4604, one skilled in the art will appreciate that other types of springs may be utilized in any of the embodiments described herein, including, but not limited to, torsion springs, disc springs, leaf springs, and the like. Furthermore, one skilled in the art will appreciate that the insertion and extraction speeds of the applicator embodiments described herein may be altered by changing the stiffness or length of the drive spring and extraction spring, respectively. Similarly, one skilled in the art will appreciate that the timing of sharps extraction may be modified by modifying the depth of the sheath channel (e.g., increasing the depth of the sheath channel will allow for earlier sharps extraction).

For any of the applicator embodiments described herein, as well as any of its component parts (including but not limited to the sharps, sharps module, and sensor module embodiments), one skilled in the art will understand that the embodiments can be sized and configured for use with a sensor configured to sense an analyte level in a bodily fluid in the epidermis, dermis, or subcutaneous tissue of a subject. For example, in some embodiments, the sharps disclosed herein and the distal portion of the analyte sensor can both be sized and configured to be positioned at a particular edge depth (i.e., the deepest penetration point within a tissue or layer of the subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). For some applicator embodiments, one skilled in the art will understand that certain embodiments of the sharps can be sized and configured to be positioned at an edge depth within the subject's body that is different from the final edge depth of the analyte sensor. For example, in some embodiments, the sharps can be positioned at a first edge depth within the epidermis of the subject prior to withdrawal, while the distal portion of the analyte sensor can be positioned at a second edge depth within the dermis of the subject. In other embodiments, the sharp can be positioned at a first end depth within the dermis of the subject prior to withdrawal, while the distal portion of the analyte sensor can be positioned at a second end depth within the subcutaneous tissue of the subject. In yet other embodiments, the sharp can be positioned at a first end depth and the analyte sensor can be positioned at a second end depth prior to withdrawal, both of which are within the same layer or tissue of the subject's body.

Further, with respect to any of the applicator embodiments described herein, including but not limited to the powered applicators of Figures 18A, 18B, and 19A-19L, one of ordinary skill in the art will recognize that an analyte sensor and one or more structural components coupled to the analyte sensor, including but not limited to one or more spring mechanisms, can be positioned within the applicator at an off-center location relative to one or more axes of the applicator. For example, in some applicator embodiments, the analyte sensor and spring mechanism can be positioned on a first side of the applicator at a first off-center location relative to the applicator axis, and the sensor electronics can be positioned on a second side of the applicator at a second off-center location relative to the applicator axis. In other applicator embodiments, the analyte sensor, spring mechanism, and sensor electronics can be positioned on the same side at an off-center location relative to the applicator axis. Those skilled in the art will appreciate that other permutations and configurations in which any or all of the analyte sensors, spring mechanisms, sensor electronics, and other components of the applicator are positioned in a central or off-center position relative to one or more axes of the applicator are possible and are fully within the scope of the present disclosure.

A number of deflectable structures are described herein, including, but not limited to, the deflectable detent snap 1402, the deflectable locking arm 1412, the sharps carrier locking arm 1524, the sharps retaining arm 1618, and the module snap 2202. These deflectable structures are constructed of a resilient material, such as plastic or metal (or other), and operate in a manner known to those skilled in the art. Each of these deflectable structures has a rest state or position toward which the resilient material is biased. When a force is applied to deflect or move the structure from the rest state or position, the bias of the resilient material causes the structure to return to the rest state or position when the force is removed (or weakened). Often, these structures are configured as arms with detents or snaps, although other structures or configurations that retain the same characteristics of deflectability and ability to return to the rest position can also be used, including, but not limited to, legs, clips, catches, abutments, etc. on the deflectable member.

Exemplary embodiments of applicator and sensor control device for single-piece architecture As mentioned above, certain embodiments of the sensor control device 102 and applicator 150 can be provided to the user in multiple packages. For example, some embodiments, such as those described with respect to FIGS. 3A-3G, can have a "two-piece" architecture that requires final assembly by the user before the sensor can be properly delivered to the target monitoring location. More specifically, the sensor and associated electronic components included in the sensor control device are provided to the user in multiple (e.g., two) packages, each of which may or may not be sealed with a sterile barrier, but which are at least housed within a package. The user must open the package and manually assemble the components according to the instructions, and then use the applicator to deliver the sensor to the target monitoring location. For example, referring again to FIGS. 3A-3G, the sensor tray and applicator are provided to the user in separate packages, thus requiring the user to open each package and perform the final assembly of the system. In some applications, this separate sealed packaging allows the tray and applicator to be sterilized in separate sterilization processes that are specific to the contents of each package and incompatible with the contents of the other.

More specifically, the tray containing the plug assembly, including the sensor and sharps, can be sterilized using radiation sterilization, such as electron beam (or "e-beam") irradiation. However, radiation sterilization can damage electronic components disposed within the housing of the sensor control device. As a result, if the applicator containing the housing of the sensor control device needs to be sterilized, it can be sterilized by another method, such as gas chemical sterilization, for example, using ethylene oxide. However, gas chemical sterilization can damage enzymes or other chemicals and biological agents contained on the sensor. Due to such sterilization incompatibilities, the tray and applicator may be sterilized in separate sterilization processes and then packaged separately, which requires the user to perform final assembly of the components upon receipt.

According to other embodiments of the present disclosure, a sensor control device (e.g., an analyte sensor device) may have a single-part architecture incorporating sterilization techniques specifically designed for the single-part architecture. This single-part architecture allows the sensor control device assembly to be shipped to a user in a single sealed package that does not require any final user assembly steps. Rather, the user need only open one package and then deliver the sensor control device to the target monitoring location. The single-part system architecture described herein may prove advantageous in terms of elimination of component parts, various fabrication process steps, and user assembly steps. As a result, packaging and waste are reduced, and the possibility of user error or contamination of the system is mitigated.

According to some embodiments, a sensor subassembly (SSA) can be constructed and sterilized. The sterilization can be radiation, such as electron beam (e-beam radiation), but other sterilization methods can be used, including but not limited to gamma radiation, x-ray radiation, or combinations thereof. An embodiment of a method for manufacturing an analyte monitoring system using the SSA is described herein, as well as an embodiment of a sensor control device having the SSA and an applicator for use therewith. The SSA can be manufactured and then sterilized. During sterilization, the SSA can include both an analyte sensor and a sharps for insertion. The sterilized SSA can then be assembled to form a sensor control device (e.g., assembled into a sensor control device), e.g., the sterilized SSA can be positioned such that the sensor is in electrical contact with any electronics in the sensor electronics carrier. The sensor control device can then be assembled (e.g., as a single-piece assembly) to form an applicator (e.g., assembled into an applicator), where the applicator (also referred to as an analyte sensor inserter) is configured to apply the sensor control device to the body of a user. This single-piece assembly can then be packaged and/or distributed (e.g., shipped) to a user or medical professional.

Figures 20A-20G show a first embodiment of an applicator for use with a sensor control device having an SSA. Figures 21A-21G show a second embodiment of an applicator for use with a sensor control device having an SSA.

Figures 22A-22G show a first embodiment of a sensor control device having an SSA but no adhesive patch. Figures 23A-23G show a second embodiment of a sensor control device having an SSA and an adhesive patch.

Figures 24A-24G show a third embodiment of a sensor control device having an SSA and a bottom groove but no adhesive patch. Figures 25A-25G show a fourth embodiment of a sensor control device having an SSA, a bottom groove, and an adhesive patch.

Figures 26A-26G show a fifth embodiment of a sensor control device having an SSA but no adhesive patch. Figures 27A-27G show a sixth embodiment of a sensor control device having an SSA and an adhesive patch.

Figures 28A-28G show a seventh embodiment of a sensor control device having an SSA and a bottom groove but no adhesive patch. Figures 29A-29G show an eighth embodiment of a sensor control device having an SSA, a bottom groove, and an adhesive patch.

According to other embodiments, the sensor control device, including the battery and the sensor, can be assembled into an applicator as a single-part assembly and sterilized using a focused electron beam (FEB). Alternatively, other methods of sterilization can be used, including, but not limited to, gamma radiation, x-ray radiation, or combinations thereof. Method embodiments for manufacturing and sterilizing an analyte monitoring system, e.g., with a FEB, are described herein, as are embodiments of a sensor control device and an applicator for use therewith. A sensor control device can be manufactured or assembled, including a sensor and sharps, e.g., the sensor can be placed in electrical contact with any electronics in a sensor electronics carrier of the sensor control device. This sensor control device can then be assembled (e.g., as a single-part assembly) to form (e.g., assembled into) an applicator, where the applicator is configured to apply the sensor control device to the body of a user. This assembled applicator with the sensor control device therein can then be sterilized, e.g., with a FEB. The sterilized applicator can then be packaged and/or distributed (e.g., shipped) to a user or medical professional. In some embodiments, a desiccant and foil seal can be added to the sterile, single-part assembly prior to packaging.

Figures 30A-30G show a first embodiment of an applicator, e.g., for sterilization with FEB. Figures 31A-31G show a second embodiment of an applicator, e.g., for sterilization with FEB.

Figures 32A-32G show a first embodiment of a sensor control device without an adhesive patch, e.g., for sterilization with a FEB. Figures 33A-33G show a second embodiment of a sensor control device with an adhesive patch, e.g., for sterilization with a FEB.

Figures 34A-34G show a third embodiment of a sensor control device with a bottom groove but no adhesive patch, e.g., for sterilization with a FEB. Figures 35A-35G show a fourth embodiment of a sensor control device with a bottom groove and an adhesive patch, e.g., for sterilization with a FEB.

For all embodiments shown and described in Figures 20A-35G, solid lines may alternatively be shown as dashed lines that do not form part of the design. For all embodiments of the sensor control device described in Figures 22A-29G and 32A-35G, adhesive patches may alternatively be shown as dashed lines when illustrated as solid lines, and adhesive patches may be shown as dashed or solid lines when not illustrated.

Various aspects of the subject matter of the present invention are described below with reference to and/or in addition to the previously described embodiments, with emphasis placed on the interrelationships and compatibility of the following embodiments. In other words, emphasis is placed on the fact that each feature of these embodiments can be combined with every other feature, unless otherwise stated or logically conceivable.

In a number of exemplary embodiments, a method of applying a medical device to a subject with an applicator is provided, the method including: positioning a distal end of the applicator on a skin surface of the subject, at least a portion of the distal end including a compressible material; applying a force to the applicator to advance the medical device from a first position within the applicator to a second position adjacent the skin surface, causing the distal end of the applicator to tension and flatten a portion of the skin surface adjacent the applicator; and applying the medical device to the tensioned and flattened portion of the skin surface.

In embodiments of these methods, the step of applying a force to the applicator may further include displacing at least a compressible portion of the distal end of the applicator in a radially outward direction. The step of displacing at least a compressible portion of the distal end of the applicator may further include generating a radially outward force against the portion of the skin surface adjacent the applicator.

In embodiments of these methods, the step of applying the medical device to the stretched and flattened portion of the skin surface may further include placing an adhesive surface on the skin surface.

In embodiments of these methods, the step of applying the medical device to the stretched and flattened portion of the skin surface may further include positioning at least a portion of an analyte sensor beneath the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject.

In these method embodiments, the at least a compressible portion of the distal end of the applicator can be biased in a radially inward direction. Alternatively, the at least a compressible portion of the distal end of the applicator can be biased in a radially outward direction.

In these method embodiments, the at least a compressible portion of the distal end can be unloaded in the first position and the at least a compressible portion of the distal end can be loaded in the second position.

In embodiments of these methods, the compressible at least a portion of the distal end of the applicator may include one or more legs or springs, or combinations thereof, of an elastomeric material, a metal, a plastic, or a composite material.

In embodiments of these methods, the cross-section of at least the compressible portion of the distal end of the applicator may include a continuous ring or a discontinuous shape.

In embodiments of these methods, the distal end of the applicator can be configured to be detached from the applicator.

In a number of exemplary embodiments, an apparatus is provided that includes: a medical device; and an applicator including a distal end configured to be positioned on a skin surface of a subject, where at least a portion of the distal end includes a compressible material, and in response to application of a force to the applicator: the medical device can be configured to advance from a first position within the applicator to a second position adjacent the skin, the distal end of the applicator can be configured to tension and flatten a portion of the skin surface adjacent the applicator, and the medical device can be further configured to be applied to the tensioned and flattened portion of the skin surface.

In these device embodiments, the compressible at least a portion of the distal end of the applicator can be configured to displace in a radially outward direction in response to the application of a force to the applicator. The compressible at least a portion of the distal end of the applicator can be further configured to generate a radially outward force against the portion of the skin surface adjacent to the applicator.

In these apparatus embodiments, the medical device can include an adhesive surface that can be configured to interface with the skin surface.

In these apparatus embodiments, the medical device can include an analyte sensor, at least a portion of which can be configured to be positioned below the skin surface. The analyte sensor can be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject.

In these device embodiments, the compressible at least portion of the distal end of the applicator can be biased in a radially inward direction. Alternatively, the compressible at least portion of the distal end of the applicator can be biased in a radially outward direction.

In these device embodiments, the at least a compressible portion of the distal end can be unloaded in the first position, and the at least a compressible portion of the distal end can be loaded in the second position.

In these device embodiments, the compressible at least a portion of the distal end of the applicator may include one or more legs or springs, or combinations thereof, of an elastomeric material, metal, plastic, or composite material.

In these device embodiments, the cross-section of at least the compressible portion of the distal end of the applicator may include a continuous ring or a discontinuous shape.

In these device embodiments, the distal end of the applicator can be configured to be detached from the applicator.

In numerous embodiments, an assembly for use in an applicator is provided, the assembly including a sharps module including a sharp portion and a hub portion, the sharp portion may include a sharps shaft, a sharps proximal end coupled to a distal end of the hub portion, and a sharps distal tip configured to penetrate a skin surface of a subject, the sharps module may further include a plastic material.

In these assembly embodiments, the sharps shaft may include one or more filleted edges.

In these assembly embodiments, the sharps module may further include a thermoplastic material.

In these assembly embodiments, the sharps module may further include a polyetheretherketone material.

In these assembly embodiments, the sharps shaft can include an alignment ledge configured to prevent rotational movement of the sharps module along a vertical axis during the insertion process. The alignment ledge can be positioned along a proximal portion of the sharps shaft.

In these assembly embodiments, the assembly may further include an analyte sensor, which may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject. A distal end of the analyte sensor may be proximal to the sharps distal tip. The distal end of the analyte sensor and the sharps distal tip may be co-located. At least a portion of the analyte sensor may be positioned within a sensor channel of the sharps shaft.

In these assembly embodiments, the sharps module may further include a liquid crystal polymer material.

In these assembly embodiments, the assembly may further include a lubricant disposed on an exterior surface of the sharps module.

In these assembly embodiments, the plastic material may include a lubricant.

In these assembly embodiments, the assembly may further include a sensor channel, at least a portion of which may be disposed at a distal portion of the sharps shaft. The sensor channel may extend from the proximal portion of the sharps shaft to the distal portion of the sharps shaft. The sensor channel may be configured not to extend beyond the distal portion of the sharps shaft. The proximal portion of the sharps shaft may be hollow. The proximal portion of the sharps shaft may be solid. A wall thickness of at least a portion of the proximal portion of the sharps shaft may be greater than a wall thickness of the distal portion of the sharps shaft.

In these assembly embodiments, the assembly may further include one or more rib structures adjacent the hub portion, the one or more rib structures may be configured to reduce compressive loads about the hub portion.

In numerous embodiments, a method of preparing an analyte monitoring system is provided, the method including: loading a sensor control device into a sensor applicator, the sensor control device including an electronics housing, a printed circuit board positioned within the electronics housing and including processing circuitry, an analyte sensor extending from a bottom of the electronics housing, and a sharps module including a plastic material and removably coupled to the electronics housing, the sharps module including a sharps that extends through the electronics housing to receive a portion of the analyte sensor extending from the bottom of the electronics housing; securing a cap to the sensor applicator to provide a barrier sealing the sensor control device within the sensor applicator; and sterilizing the analyte sensor and the sharps with radiation while the sensor control device remains positionable within the sensor applicator.

In these method embodiments, the sensor control device may further include at least one shield positioned within the electronics housing, and the method may further include shielding the processing circuitry from the radiation with the at least one shield during the sterilization. The at least one shield may include a magnet, and shielding the processing circuitry with the at least one shield may include: generating a static magnetic field using the magnet; and using the static magnetic field to deflect the radiation away from the processing circuitry. Sterilizing the analyte sensor and the sharps with radiation may further include sterilizing the analyte sensor and the sharps with an unfocused electron beam.

In embodiments of these methods, the analyte sensor can be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid located within the subject.

In embodiments of these methods, the sharps module may further include a thermoplastic material.

In embodiments of these methods, the sharps module may further include a polyetheretherketone material.

In embodiments of these methods, the step of sterilizing the analyte sensor and the sharps may further include focusing an electron beam onto the analyte sensor and the sharps.

In numerous embodiments, an assembly for use in an applicator is provided, the assembly including a sharps module including a sharp portion and a hub portion, the sharp portion can include a sharps shaft, a sharps proximal end coupled to a distal end of the hub portion, and a sharps distal tip configured to penetrate a skin surface of a subject, the sharp portion can further include a metallic material and can be formed by a coining process.

In these assembly embodiments, the sharp portion may further comprise a stainless steel material.

In these assembly embodiments, the sharp portion does not include a sharp edge.

In these assembly embodiments, the sharp portion may include one or more rounded edges.

In these assembly embodiments, the sharps shaft may include one or more rounded edges.

In these assembly embodiments, the sharps shaft and the sharps distal tip may include one or more rounded edges.

In these assembly embodiments, the assembly may further include an analyte sensor, which may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject. A distal end of the analyte sensor may be proximal to the sharps distal tip. The distal end of the analyte sensor and the sharps distal tip may be co-located. At least a portion of the analyte sensor may be positioned within a sensor channel of the sharps shaft.

In a number of embodiments, a method is provided for maintaining the structural integrity of a sensor control unit including an analyte sensor and a sensor module, the method including: positioning a distal sensor portion of the analyte sensor below a skin surface and in contact with a bodily fluid, the analyte sensor may include a proximal sensor portion coupled to the sensor module, the proximal sensor portion including a hook-like feature adjacent to a catch-like feature of the sensor module; subjecting the analyte sensor to one or more forces in a proximal direction along a longitudinal axis; and engaging the hook-like feature with the catch-like feature to prevent displacement of the analyte sensor in the proximal direction along the longitudinal axis.

In these method embodiments, the method may further include loading the analyte sensor into the sensor module by laterally displacing the proximal sensor portion to bring the hook feature proximal to the catch feature of the sensor module. The laterally displacing the proximal sensor portion may include moving the proximal sensor portion into a clearance area of the sensor module.

In embodiments of these methods, the one or more forces can be generated by a sharps extraction process.

In embodiments of these methods, the one or more forces can be generated by a physiological response to the analyte sensor.

In embodiments of these methods, the analyte sensor can be an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.

In a number of embodiments, a sensor control unit is provided that includes: a sensor module including a catch-like feature; and an analyte sensor including a distal sensor portion and a proximal sensor portion, the distal sensor portion being configured to be positioned below a skin surface and in contact with bodily fluids, the proximal sensor portion being connectable to the sensor module and including a hook-like feature adjacent to the catch-like feature, the hook-like feature being configured to engage with the catch-like feature to prevent displacement of the analyte sensor in a proximal direction along a longitudinal axis of the analyte sensor caused by one or more forces experienced by the analyte sensor.

In these sensor control unit embodiments, the sensor module can be configured to receive the analyte sensor by laterally displacing the proximal sensor portion to bring the hook feature proximal to the catch feature of the sensor module. The sensor module can further include a clearance area configured to receive the proximal sensor portion when the proximal sensor portion can be laterally displaced.

In these sensor control unit embodiments, the one or more forces can be generated by a sharps extraction process.

In these sensor control unit embodiments, the one or more forces can be generated by a physiological response to the analyte sensor.

In these sensor control unit embodiments, the analyte sensor can be an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.

In a number of embodiments, a method is provided for inserting an analyte sensor into a subject's body using an applicator, the method including: positioning a distal end of the applicator on a skin surface, the applicator may include a drive spring, an extraction spring, a sensor electronics carrier, a sharps carrier, and the analyte sensor; applying a first force to the applicator, causing the drive spring to displace the sensor electronics carrier and the sharps carrier from a first position within the applicator in spaced relation to the skin surface to a second position adjacent the skin surface and position a sharp of the sharps carrier and a portion of the analyte sensor below the skin surface and in contact with a bodily fluid of the subject; and applying a second force to the applicator, causing the extraction spring to displace the sharps carrier from the second position to a third position within the applicator and extract the sharps from the skin surface.

In embodiments of these methods, the step of applying the first force can include applying a force in a distal direction, and the step of applying the second force can include applying a force in a proximal direction.

In embodiments of these methods, the applicator may further include a firing pin and a sheath, and the step of applying the first force to the applicator further causes the firing pin to disengage one or more sheath tabs of the sheath from one or more sensor electronics carrier latches of the sensor electronics carrier and extends the drive spring. The drive spring may be preloaded prior to the step of applying the first force, and by disengaging the one or more sheath tabs, the drive spring extends in a distal direction. The step of applying the first force to the applicator increases the load on the drive spring prior to causing the firing pin to disengage the one or more sheath tabs. The drive spring may be preloaded prior to the step of applying the first force, and the drive spring may include a first end coupled to the firing pin and a second end coupled to the sensor electronics carrier.

In these method embodiments, the applicator may further include a sensor control unit coupled to the sensor electronics carrier, a distal portion of the sensor control unit capable of contacting the skin surface at the second position. The step of displacing the sensor electronics carrier and the sharps carrier from the first position to the second position may include a step of one or more sensor electronics carrier tabs of the sensor electronics carrier moving distally along one or more sheath rails of the sheath. One or more sensor electronics carrier bumpers of the sensor electronics carrier may be biased against an inner surface of the sheath while the sensor electronics carrier and the sharps carrier are displaced from the first position to the second position.

In embodiments of these methods, the step of applying the second force further disengages a plurality of sensor electronics carrier lock arms of the sensor electronics carrier from the sharps carrier and extends the extraction spring. The step of disengaging the plurality of sensor electronics carrier lock arms from the sharps carrier can include positioning the plurality of sensor electronics carrier lock arms into a plurality of sheath notches of the sheath. Each of the plurality of sensor electronics carrier lock arms can be biased in a radially outward direction, and the sheath notches can be configured to extend the plurality of sensor electronics carrier lock arms in a radially outward direction. The extraction spring can be preloaded prior to the step of applying the second force, and the step of disengaging the plurality of sensor electronics carrier lock arms extends the extraction spring in a proximal direction.

In embodiments of these methods, the extraction spring may be preloaded prior to the step of applying the second force, and the extraction spring may include a first end coupled to the sharps carrier and a second end coupled to the sensor electronics carrier.

In embodiments of these methods, the step of applying the second force further causes the drive spring to displace the sensor electronics carrier toward a bottom portion of the applicator.

In embodiments of these methods, the analyte sensor can be an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.

In a number of embodiments, an applicator for inserting an analyte sensor into a subject's body is provided, the applicator including: a drive spring; an extraction spring; a sensor electronics carrier; a sharps carrier coupled to a sharps; and the analyte sensor, the drive spring being configured to displace the sensor electronics carrier and the sharps carrier from a first position within the applicator in spaced relation to a skin surface to a second position adjacent the skin surface upon application of a first force to the applicator, the sharps and a portion of the analyte sensor being positioned below the skin surface and in contact with bodily fluid of the subject at the second position, and the extraction spring being configured to displace the sharps carrier from the second position to a third position within the applicator and extract the sharps from the skin surface upon application of a second force to the applicator.

In these applicator embodiments, the application of the first force can include application of a distal force and the application of the second force can include application of a proximal force.

In these applicator embodiments, the applicator may further include a firing pin and a sheath, and the firing pin may be configured to disengage one or more sheath tabs of the sheath from one or more sensor electronics carrier latches of the sensor electronics carrier and extend the drive spring upon application of the first force. The drive spring may be in a preloaded state prior to the application of the first force, and the drive spring may be configured to extend distally in response to the one or more sheath tabs being disengaged from the one or more sensor electronics carrier latches. The drive spring may be configured to receive an increased load before the firing pin disengages the one or more sheath tabs. The drive spring may be in a preloaded state prior to the application of the first force, and the drive spring may include a first end coupled to the firing pin and a second end coupled to the sensor electronics carrier.

In these applicator embodiments, the applicator may further include a sensor control unit coupled to the sensor electronics carrier, and a distal portion of the sensor control unit may be configured to contact the skin surface at the second location.

In these applicator embodiments, the applicator may further include one or more sensor electronics carrier tabs of the sensor electronics carrier that are configured to move distally along one or more sheath rails of the sheath between the first position and the second position.

In these applicator embodiments, the applicator may further include one or more sensor electronics carrier bumpers on the sensor electronics carrier, which may be configured to be biased against an inner surface of the sheath between the first position and the second position.

In these applicator embodiments, the applicator may further include a plurality of sensor electronics carrier locking arms of the sensor electronics carrier, the sensor electronics carrier locking arms may be configured to disengage from the sharps carrier and extend the extraction spring in response to the application of the second force. The applicator may further include a plurality of sheath notches of the sheath, the plurality of sheath notches may be configured to receive the plurality of sensor electronics carrier locking arms and disengage the sensor electronics carrier locking arms from the sharps carrier. Each of the plurality of sensor electronics carrier locking arms may be biased in a radially outward direction, the sheath notches may be configured to extend the plurality of sensor electronics carrier locking arms in a radially outward direction. The extraction spring may be in a preloaded state prior to the application of the second force, the extraction spring may be configured to extend in a proximal direction when the plurality of sensor electronics carrier locking arms disengage from the sharps carrier.

In these applicator embodiments, the extraction spring may be preloaded prior to the application of the second force, and the extraction spring may include a first end coupled to the sharps carrier and a second end coupled to the sensor electronics carrier.

In these applicator embodiments, the drive spring may be further configured to displace the sensor electronics carrier toward a bottom portion of the applicator in response to the application of the second force.

In these applicator embodiments, the analyte sensor can be an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.

In numerous embodiments, an assembly for use in an applicator is provided, the assembly including a sharps module including a sharp portion and a hub portion, the sharp portion can include a sharps shaft, a sharps proximal end coupled to the hub portion, and a sharps distal tip configured to penetrate a skin surface of a subject, the sharps shaft including a sensor channel configured to receive at least a portion of an analyte sensor, the sensor channel can be in a spaced relationship relative to the sharps distal tip, the sharps distal tip including an offset tip portion configured to form an opening in the skin surface.

In these assembly embodiments, the sharps module may further include a stainless steel material.

In these assembly embodiments, the sharps module may further include a plastic material.

In these assembly embodiments, the offset tip portion can be further configured to prevent damage to the sensor tip portion of the analyte sensor during the sensor insertion process.

In these assembly embodiments, the cross-sectional area of the offset tip portion can be smaller than the cross-sectional area of the sharps shaft.

In these assembly embodiments, the offset tip portion may include a separate element that is coupled to the sharps shaft.

In these assembly embodiments, the sensor channel can include one or more sidewalls of the sharps shaft. The offset tip portion can be formed from a portion of the one or more sidewalls of the sharps shaft. The sensor channel can include a first sidewall and a second sidewall, and the offset tip portion can be formed from a terminus of the first sidewall of the sharps shaft, and the terminus of the second sidewall can be proximal to the terminus of the first sidewall.

In many embodiments, a method of manufacturing an analyte monitoring system is provided, the method including: sterilizing a sensor subassembly including a sensor and a sharps; assembling the sterilized sensor subassembly into a sensor control device; assembling the sensor control device into an applicator; and packaging the applicator with the sensor control device therein for distribution.

In embodiments of these methods, the sensor control device may be as shown or substantially as shown in any of Figures 20A-21G.

In these method embodiments, the applicator can be as shown or substantially as shown in any of Figures 22A-29G.

In many embodiments, a method of manufacturing an analyte monitoring system is provided, the method including: assembling a sensor control device including a sensor and a sharps; assembling the sensor control device into an applicator; sterilizing the applicator with the sensor control device therein with a focused electron beam; and packaging the applicator with the sensor control device therein for distribution.

In embodiments of these methods, the sensor control device may be as shown or substantially as shown in any of Figures 30A-31G.

In these method embodiments, the applicator can be as shown or substantially as shown in any of Figures 32A-35G.

It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and replaceable with features, elements, components, functions, and steps from any other embodiment. If a particular feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that the feature, element, component, function, or step can be used with all other embodiments described herein, unless otherwise stated. Thus, this paragraph serves as a predicate and written support for introducing claims that combine features, elements, components, functions, and steps from different embodiments at any time, or replace features, elements, components, functions, and steps from one embodiment with those from another embodiment, even if the following description does not expressly state that such combinations or substitutions are possible in a particular example. It is clearly recognized that an explicit enumeration of all possible combinations and substitutions would be an undue burden, especially when a person skilled in the art would readily recognize that all such combinations and substitutions are each permissible.

These embodiments are susceptible to various modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. However, it should be understood that these embodiments are not limited to the particular forms disclosed, but on the contrary, these embodiments can encompass all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any feature, function, step, or element of these embodiments can be recited or added to the claims, and negative limitations that define the scope of the claimed invention by any feature, function, step, or element not within the scope of the claims can also be recited or added to the claims.

The following describes preferred embodiments of the present invention.

EMBODIMENT 1
1. An assembly for use in an applicator, comprising:
The assembly comprises:
a sharps module comprising a sharp portion and a hub portion, the sharp portion comprising a sharps shaft, a sharps proximal end coupled to a distal end of the hub portion, and a sharps distal tip configured to penetrate a skin surface of a subject;
The assembly, wherein the sharp portion further comprises a metallic material and is formed by a coining process.

EMBODIMENT 2
2. The assembly of embodiment 1, wherein the sharp portion further comprises a stainless steel material.

EMBODIMENT 3
2. The assembly of embodiment 1, wherein the sharp portion does not include a sharp edge.

EMBODIMENT 4
2. The assembly of embodiment 1, wherein the sharp portion comprises one or more rounded edges.

EMBODIMENT 5
2. The assembly of embodiment 1, wherein the sharps shaft comprises one or more rounded edges.

EMBODIMENT 6
2. The assembly of embodiment 1, wherein the sharps shaft and the sharps distal tip comprise one or more rounded edges.

EMBODIMENT 7
The assembly further comprises an analyte sensor;
2. The assembly of embodiment 1, wherein the analyte sensor is an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject.

EMBODIMENT 8
8. The assembly of embodiment 7, wherein a distal end of the analyte sensor is in a proximal position relative to the distal tip of the sharp.

EMBODIMENT 9
8. The assembly of embodiment 7, wherein the distal end of the analyte sensor and the distal tip of the sharps are in the same location.

EMBODIMENT 10
8. The assembly of embodiment 7, wherein at least a portion of the analyte sensor is positioned within a sensor channel of the sharps shaft.

EMBODIMENT 11
1. A method of maintaining structural integrity of a sensor control unit comprising an analyte sensor and a sensor module, the method comprising:
The method comprises:
positioning a distal sensor portion of the analyte sensor beneath a skin surface and in contact with a bodily fluid, the analyte sensor comprising a proximal sensor portion coupled to the sensor module, the proximal sensor portion including a hook-like feature adjacent to a catch-like feature of the sensor module;
receiving one or more forces in a proximal direction along a longitudinal axis of the analyte sensor; and engaging the hook-like feature with the catch-like feature to prevent displacement of the analyte sensor in the proximal direction along the longitudinal axis.

EMBODIMENT 12
12. The method of embodiment 11, further comprising loading the analyte sensor into the sensor module by laterally displacing the proximal sensor portion to bring the hook-like feature proximal to the catch-like feature of the sensor module.

EMBODIMENT 13
13. The method of embodiment 12, wherein the step of laterally displacing the proximal sensor portion includes moving the proximal sensor portion into a clearance area of the sensor module.

EMBODIMENT 14
12. The method of embodiment 11, wherein the one or more forces are generated by a sharps extraction process.

EMBODIMENT 15
12. The method of embodiment 11, wherein the one or more forces are generated by a physiological response to the analyte sensor.

EMBODIMENT 16
12. The method of embodiment 11, wherein the analyte sensor is an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.

EMBODIMENT 17
A sensor control unit,
The sensor control unit:
a sensor module including a catch-like feature; and an analyte sensor comprising a distal sensor portion and a proximal sensor portion, the distal sensor portion configured to be positioned below a skin surface and in contact with a bodily fluid, the proximal sensor portion coupled to the sensor module and comprising a hook-like feature adjacent to the catch-like feature;
A sensor control unit configured to engage the hook-like feature with the catch-like feature to prevent displacement of the analyte sensor in a proximal direction along a longitudinal axis of the analyte sensor caused by one or more forces experienced by the analyte sensor.

EMBODIMENT 18
A sensor control unit as described in embodiment 17, wherein the sensor module is configured to receive the analyte sensor by laterally displacing the proximal sensor portion to bring the hook-like feature proximal to the catch-like feature of the sensor module.

EMBODIMENT 19
19. A sensor control unit as described in embodiment 18, wherein the sensor module further comprises a clearance area configured to receive the proximal sensor portion when the proximal sensor portion is displaced laterally.

EMBODIMENT 20
18. A sensor control unit as described in embodiment 17, wherein the one or more forces are generated by a sharps extraction process.

EMBODIMENT 21
18. The sensor control unit of embodiment 17, wherein the one or more forces are generated by a physiological response to the analyte sensor.

EMBODIMENT 22
18. The sensor control unit of embodiment 17, wherein the analyte sensor is an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.

100 Analyte monitoring system 102 Sensor control device 104 Sensor, analyte sensor, in vivo analyte sensor 105 Adhesive patch 120 Reader device 121 Input, input components 122 Screen, display 123 Power port 140-144 Communication path 150 Sensor applicator 160 Sensor electronics 161 Semiconductor chip, ASIC
162 Analog Front End (AFE), semiconductor chip 163, 165, 223, 225, 230 Memory 164 Power management (or control) circuitry 166 Processor 168 Communications circuitry 170 Local computer system 170 Power supply 171, 229, 234 Antenna 174 Semiconductor chip 180 Trusted computer system 190 Network 206 Processing core 207 Plug assembly 221 Target monitoring location 222 Communications processor 224 Application processor 226 Power supply 228 RF transceiver 232 Multifunction transceiver 238 Power management module 502 Desiccant 504 Sensor module 702 Applicator housing 704 Sheath 706 Electronics housing 708 Applicator cap, screw cap, cap 710 Sensor electronics carrier 808 Platform 810 sensor container, sensor tray 812 lid, sterile lid 1302 housing orientation feature 1304 tamper ring groove 1306 tamper ring retainer 1310 housing threads 1314 tamper ring protector 1316 side grip zone 1318 grip protrusion 1320 shark teeth 1321 housing guide structure, guide rib, housing guide rib, structure 1322 insertion hard stop 1326 guide edge, sheath guide rail 1327 carrier interface post 1328 sensor electronics carrier interface 1330 sheath snap-in feature 1332 locking groove 1334 unlock groove 1336 final lockout groove, final lockout recess 1338 sheath stop ramp 1340 structure, locking rib 1344 firing detent 1346 Central axis 1402 detent snap 1404 detent snap curved portion 1406 detent snap flat portion 1408 detent snap bridge 1410 detent clearance 1412 locking arm 1414 locking arm reinforcing rib 1416 locking arm interface 1418 guide rail 1420 sensor electronics carrier travel limiter surface 1422 detent snap reinforcing feature 1424 alignment notch 1426 reinforcing rib 1428 housing guide rail clearance 1436 detent base 1446 guide rail rear wall 1448 sheath rotation limiter 1450 compressible distal end 1451 octagonal geometry 1452 star geometry 1453 discontinuous ring geometry 1454 discontinuous rectangular geometry 1502 locking interface 1506 Rotation limiter 1510 Aperture 1516 Spring alignment ridge 1518 Sensor electronics retention spring arm 1519 Detent 1524 Sharps carrier lock arm 1526 Detent or retention feature 1534 Shock lock 1608 Anti-rotation slot 1610 Sharps carrier base chamfer 1618 Sharps retention arm 1620 Sharps retention clip 1622 Sharps hub contact surface 1834 Retention arm extension 2200 Module 2202 Module snap 2208 Sharps slot 2212 Sensor ledge 2216 Sensor wall 2300 Connector 2302 Conductive contacts 2304 Sealing surface 2308 Hinge 2404 Flag 2406 Neck 2408 Tail 2412 bias tower 2414 bias fulcrum 2416 bias adjuster 2418 contact 2420 service loop 2500 sharps module 2502 sharps, metal sharps 2504 sharps shaft 2506 distal tip, sharps distal tip 2508 hub press cylinder 2512 hub mini cylinder 2514 hub snap tab placement cylinder 2516 hub snap tab 2545 vertical axis 2550 plastic sharps module 2554 sharps shaft 2556 sharps distal tip 2558 sensor channel 2562 hub 2568 alignment feature 2570 plastic sharps module 2574 sharps shaft 2575 proximal portion 2576 Sharps distal tip 2577 Distal portion 2578 Sensor channel 2582 Hub, sharps hub portion 2602 Cast sharps 2606 Sharps distal tip 2620 Sharps module 2624 Sharps shaft 2626 Distal tip 2627 Offset tip portion 2628 Sensor channel 2629 Sidewall 2632 Hub 2644 Sharps shaft 2646 Distal tip 2647 Offset tip portion 2648 Sensor channel 2649a First sidewall 2649b Second sidewall 2652 Hub 3104 Sensor 3106 Hook-like feature 3504 Sensor module 3506 Catch-like feature 3508 Clearance area 4150 Powered applicator 4524 sensor electronics carrier lock arm 4602 sharp part carrier 4603 sensor electronics carrier latch 4604 extraction spring 4605 sensor electronics carrier tab 4606 drive spring 4607 sensor electronics carrier bumper 4702 housing 4704 sheath 4705 firing pin 4706 sheath tab 4707 sheath rail 4708 sheath notch 4710 sensor electronics carrier

Claims (16)

1. An applicator for inserting an analyte sensor into a subject, comprising:
Drive spring,
Extraction spring,
Sensor electronics carrier,
a sharps carrier having a sharps portion; and an analyte sensor;
an applicator, wherein the drive spring is configured to displace a sensor electronics carrier and a sharps carrier from a first position within the applicator in spaced relationship to a skin surface to a second position adjacent to the skin surface, where the sharps and a portion of the analyte sensor are positioned below the skin surface and in contact with a bodily fluid of the subject at the second position; and an extraction spring is configured to displace the sharps carrier from the second position to a third position within the applicator and extract the sharps from the skin surface upon application of a second force to the applicator. The applicator of claim 1, wherein the application of the first force includes application of a force in a distal direction and the application of the second force includes application of a force in a proximal direction. The applicator of claim 1, further comprising a firing pin and a sheath, the firing pin configured to disengage one or more sheath tabs of the sheath from one or more sensor electronics carrier latches of the sensor electronics carrier upon application of the first force, thereby extending the drive spring. The applicator of claim 3, wherein the drive spring is in a preloaded state prior to the application of the first force and is configured to extend distally by disengaging the one or more sheath stubs from the one or more sensor electronics carrier latches. The applicator of claim 3, wherein the drive spring is subjected to an increased load before the firing pin disengages from the one or more sheath stubs. The applicator of claim 3, wherein the drive spring is in a preloaded state prior to the application of the first force and includes a first end that couples to the firing pin and a second end that couples to the sensor electronics carrier. The applicator of claim 3, further comprising one or more sensor electronics carrier tabs of the sensor electronics carrier configured to move distally along one or more sheath rails of the sheath between the first position and the second position. The applicator of claim 3, further comprising one or more sensor electronics carrier bumpers of the sensor electronics carrier configured to bias against an inner surface of the sheath between the first position and the second position. The applicator of claim 1, further comprising a sensor control unit coupled to the sensor electronics carrier, a distal portion of the sensor control unit configured to contact the skin surface at the second location. The applicator of claim 1, further comprising a plurality of sensor electronics carrier locking arms on the sensor electronics carrier, the sensor electronics carrier locking arms configured to disengage from the sharps carrier and extend the extraction spring upon the application of the second force. The applicator of claim 10, further comprising a plurality of sheath notches in the sheath, the plurality of sheath notches configured to receive the plurality of sensor electronics carrier locking arms and disengage the sensor electronics carrier locking arms from the sharps carrier. The applicator of claim 11, wherein each of the plurality of sensor electronics carrier lock arms is biased in a radially outward direction, and the sheath notch is configured to allow the plurality of sensor electronics carrier lock arms to be extendable in the radially outward direction. The applicator of claim 10, wherein the extraction spring is in a preloaded state prior to the application of the second force, and the extraction spring is configured to extend proximally when the plurality of sensor electronics carrier locking arms disengage from the sharps carrier. The applicator of claim 1, wherein the extraction spring is in a preloaded state prior to the application of the second force, and the extraction spring includes a first end that couples to the sharps carrier and a second end that couples to the sensor electronics carrier. The applicator of claim 1, wherein the drive spring is configured to displace the sensor electronics carrier toward a bottom portion of the applicator upon the application of the second force. The applicator of claim 1 , wherein the analyte sensor is an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.